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OpenTrials
Completed

NCT Number: NCT01923740

A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Stenosis Coronary Disease Coronary Restenosis Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Vascular

Santa Clara, California, 95054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be at least 18 years of age at the time of signing the informed consent form.
  • Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
  • Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
  • Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Female subject of childbearing potential does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 14 days (≤14 days) prior to the index procedure per site standard test.
  • Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
  • Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure.

Exclusion criteria

  • Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure.
  • Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  • Subject has a known allergic reaction, hypersensitivity or contraindication to:
  • Aspirin; or
  • All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or
  • Heparin and bivalirudin.
  • Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure.
  • Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  • Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following criteria is met:
  • Subject requires coumadin or any other agent for chronic oral anticoagulation.
  • Subject likely to become hemodynamically unstable due to their arrhythmia.
  • Subject has poor survival prognosis due to their arrhythmia.
  • Subject has a known left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
  • Subject has received CABG at any time in the past.
  • Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure.
  • Subject requires future staged PCI either in target or non-target vessels.
  • Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  • At the time of screening, the subject has a malignancy that is not in remission.
  • Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  • Subject has previously received or is scheduled to receive radiotherapy to coronary artery (vascular brachytherapy), or chest/mediastinum.
  • Subject is receiving or will receive chronic anticoagulation therapy (e.g., coumadin or any other anticoagulation agents).
  • Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  • Subject has a known or documented hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • Subject has known renal insufficiency as defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
  • Subject is high risk of bleeding; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months; will refuse blood transfusions.
  • Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months or any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
  • Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the subject if radial or brachial access can be used.
  • Subject has life expectancy < 2 years for any non-cardiac cause or cardiac cause.
  • Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint or protocol-required medications or invasive procedures.

Angiographic Inclusion Criteria

Assessment of angiographic eligibility is per visual assessment by an investigator both for qualitative and quantitative variables. On-line QCA is recommended to be used for appropriately sizing of the vessel. If on-line QCA cannot be used, visual estimation is required.

  • One or two de novo target lesions:
  • If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
  • If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria.
  • The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.
  • Target lesion must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.
  • Target lesion must have a Dmax (by on-line QCA) or reference vessel diameter (RVD) (by visual estimation) ≥ 2.50 mm and ≤ 3.75 mm (on-line QCA assessment is recommended).
  • Target lesion must have a lesion length ≤ 24 mm based on either visual estimation or on-line QCA.

Angiographic Exclusion Criteria

All exclusion criteria apply to the target lesion(s) or target vessel(s). All exclusion criteria are based on visual estimation.

  • Target lesion is located in left main.
  • Aorto-ostial RCA target lesion (within 3 mm of the ostium).
  • Target lesion located within 3 mm of the origin of the LAD or LCX.
  • Lesion involving a bifurcation with a:
  • Side branch ≥ 2 mm in diameter, or
  • Side branch with diameter stenosis ≥ 50%, or
  • Side branch requiring protection guide wire, or
  • Side branch requiring pre-dilatation
  • Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE V, including:
  • Extreme angulation (≥ 90°) proximal to or within the target lesion
  • Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion
  • Moderate or heavy calcification proximal to or within the target lesion
  • Target lesion or target vessel involves a myocardial bridge.
  • Target vessel contains thrombus as indicated in the angiographic images.
  • Target vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE V would need to cross the stent to reach the target lesion.
  • Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.
  • Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
  • Residual %DS is < 40% (per visual estimation), ≤ 20% is strongly recommended.
  • TIMI Grade-3 flow (per visual estimation).
  • No angiographic complications (e.g. distal embolization, side branch closure).
  • No dissections National Heart, Lung, and Blood Institute (NHLBI) grade D-F.
  • No chest pain lasting > 5 minutes.
  • No ST depression or elevation lasting > 5 minutes.

Treatment and study plan

XIENCE V EECSS

Device

Subjects receiving XIENCE V

Absorb BVS System

Device

Subjects receiving Absorb BVS System

Primary outcomes

  1. In-segment Late Loss (LL) - Per Subject Analysis

    Time frame: 1 year

    In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

  2. In-segment Late Loss (LL) - Per Lesion Analysis

    Time frame: 1 year

    In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

Secondary outcomes

  1. Acute Device Success

    Time frame: < or = 1 day

    Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.

    Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

  2. Number of Participants With Acute Procedural Success

    Time frame: At time of procedure up to 7 days in hospital

    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success.

    Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

  3. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: ≤ 7 days post index procedure (In-hospital )

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  4. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 0 to 37days

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  5. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 0 to 208 days

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  6. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 0 to 298 days

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  7. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 1 year

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  8. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 2 year

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  9. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 3 years

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  10. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 4 years

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  11. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Time frame: 5 years

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

  12. Number of Participants With Myocardial Infarction

    Time frame: ≤ 7 days post index procedure (In-hospital )

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  13. Number of Participants With Myocardial Infarction

    Time frame: 0 to 37 days

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  14. Number of Participants With Myocardial Infarction

    Time frame: 0 to 208 days

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  15. Number of Participants With Myocardial Infarction

    Time frame: 0 to 298 days

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  16. Number of Participants With Myocardial Infarction

    Time frame: 1 year

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  17. Number of Participants With Myocardial Infarction

    Time frame: 2 year

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  18. Number of Participants With Myocardial Infarction

    Time frame: 3 years

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  19. Number of Participants With Myocardial Infarction

    Time frame: 4 years

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  20. Number of Participants With Myocardial Infarction

    Time frame: 5 years

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

  21. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  22. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 0 to 37 days

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  23. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 0 to 208 days

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  24. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 0 to 298 days

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  25. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 1 year

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  26. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 2 year

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  27. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 3 years

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  28. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 4 years

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  29. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 5 years

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

  30. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  31. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 0 to 37 days

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  32. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 0 to 208 days

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  33. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 0 to 298 days

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  34. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 1 year

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  35. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 2 year

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  36. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 3 years

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  37. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 4 years

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  38. Number of Participants With Target Vessel Revascularization (TVR)

    Time frame: 5 years

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

  39. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: ≤ 7 days post index procedure (In-hospital )

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  40. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 0 to 37days

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  41. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 0 to 208 days

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  42. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 0 to 298 Days

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  43. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 1 year

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  44. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 2 year

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  45. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 3 years

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  46. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 4 years

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  47. Number of Participants With All Coronary Revascularization (PCI and CABG)

    Time frame: 5 years

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

  48. Number of Death/All MI

    Time frame: ≤ 7 days post index procedure (In-hospital )

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  49. Number of Death/All MI

    Time frame: 0 to 37 days

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  50. Number of Death/All MI

    Time frame: 0 to 208 days

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  51. Number of Death/All MI

    Time frame: 0 to 298 days

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  52. Number of Death/All MI

    Time frame: 1 year

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  53. Number of Death/All MI

    Time frame: 2 year

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  54. Number of Death/All MI

    Time frame: 3 years

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  55. Number of Death/All MI

    Time frame: 4 years

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  56. Number of Death/All MI

    Time frame: 5 years

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

  57. Number of Cardiac Death/All MI

    Time frame: ≤ 7 days post index procedure (In-hospital )

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  58. Number of Cardiac Death/All MI

    Time frame: 0 to 37 days

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  59. Number of Cardiac Death/All MI

    Time frame: 0 to 208 days

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  60. Number of Cardiac Death/All MI

    Time frame: 0 to 298 days

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  61. Number of Cardiac Death/All MI

    Time frame: 1 year

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  62. Number of Cardiac Death/All MI

    Time frame: 2 year

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  63. Number of Cardiac Death/All MI

    Time frame: 3 years

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  64. Number of Cardiac Death/All MI

    Time frame: 4 years

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  65. Number of Cardiac Death/All MI

    Time frame: 5 years

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  66. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: ≤ 7 days post index procedure (In-hospital )

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  67. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 0 to 37 days

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  68. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 0 to 208 days

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  69. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 0 to 298 days

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  70. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 1 year

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  71. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 2 year

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  72. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 3 years

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  73. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 4 years

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  74. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 5 years

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

  75. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: ≤ 7 days post index procedure (In-hospital )

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  76. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 0 to 37 days

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  77. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 0 to 208 days

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  78. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 0 to 298 days

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  79. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 1 year

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  80. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 2 year

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  81. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 3 years

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  82. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 4 years

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  83. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Time frame: 5 years

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

  84. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: ≤ 7 days post index procedure (In-hospital)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  85. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 0 to 37 days

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  86. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 0 to 208 days

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  87. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 0 to 298 days

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  88. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 1 year

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  89. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 2 year

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  90. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 3 years

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  91. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 4 years

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  92. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

    Time frame: 5 years

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  93. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: ≤ 7 days post index procedure (In-hospital )

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

  94. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 0 to 37 days

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

  95. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 0 to 208 days

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  96. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 0 to 298 days

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).

  97. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 1 year

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  98. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 2 year

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  99. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 3 years

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  100. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 4 years

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  101. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    Time frame: 5 years

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  102. Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)

    Time frame: < or = 1 day

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  103. Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: >1 to 30 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  104. Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: 31 to 365 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  105. Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: 366 to 730 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  106. Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: 731 to 1095 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  107. Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: 366-1095 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  108. Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: 1096-1460 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  109. Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: 1461-1825 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  110. Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: 1096-1825 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  111. Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis

    Time frame: 0-1825 days

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  112. In-Device Minimum Lumen Diameter (MLD)

    Time frame: 1 year

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

  113. In-Segment Minimum Lumen Diameter (MLD)

    Time frame: 1 year

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

  114. Proximal Minimum Lumen Diameter (MLD)

    Time frame: 1 year

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

  115. Distal Minimum Lumen Diameter (MLD)

    Time frame: 1 year

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

  116. In-Segment Percent Diameter Stenosis (%DS)

    Time frame: 1 year

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

  117. In-Device Percent Diameter Stenosis (%DS)

    Time frame: 1 year

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

  118. Proximal Percent Diameter Stenosis (%DS)

    Time frame: 1 year

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

  119. Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)

    Time frame: 1 year

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

  120. Distal Percent Diameter Stenosis (%DS)

    Time frame: 1 year

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

  121. Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)

    Time frame: 1 year

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

  122. Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)

    Time frame: 1 year

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

  123. In-Segment Late Loss (LL)

    Time frame: 1 year

    In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).

  124. Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)

    Time frame: 1 year

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

  125. In-Device Late Loss (LL)

    Time frame: 1 year

    In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).

  126. Proximal Late Loss (LL)

    Time frame: 1 year

    Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup.

    Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.

  127. Distal Late Loss (LL)

    Time frame: 1 year

    Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup.

    Distal is defined as within 5 mm of healthy tissue distal to the device placement.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

A Clinical Evaluation of Absorb™ BVS, the Bioresorbable Vascular Scaffold, in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Chinese Population

Acronym: ABSORB CHINA

Important dates

Study start
2013
Primary completion
2015
Study completion
2019
First posted
Aug 16, 2013
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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