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Completed

NCT Number: NCT01751906

ABSORB III Randomized Controlled Trial (RCT)

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

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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

Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

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About this study

ABSORB III RCT:

A. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

B. Powered Secondary Objectives:

  • Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.

  • Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

Who can participate

Healthy volunteers accepted: No

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

General Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
  • Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives 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 who 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 7 days prior to the index procedure per site standard.
  • 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 or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

  • 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 must satisfy the angiographic eligibility criteria.
  • The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
  • Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and < 100% with a 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.
  • Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
  • Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
  • For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

General Exclusion Criteria:

  • Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
  • Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  • Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  • Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
  • Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  • Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:
  • Subject requires coumadin or any other agent for chronic oral anticoagulation.
  • Subject is likely to become hemodynamically unstable due to their arrhythmia.
  • Subject has poor survival prognosis due to their arrhythmia.
  • Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with 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 undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
  • Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure
  • 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 severe autoimmune disease that requires chronic immunosuppressive therapy (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 a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  • Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
  • Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  • Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening.
  • Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  • Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or 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 patient if radial access may be used.
  • Subject has life expectancy < 5 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. This includes completion of Patient Reported Outcome instruments.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  • Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

  • Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
  • Residual %DS is a maximum < 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 NHLBI grade D-F.
  • No chest pain lasting > 5 minutes.
  • No ST depression or elevation lasting > 5 minutes.
  • Lesion is located in left main.
  • Aorto-ostial RCA lesion (within 3 mm of the ostium).
  • 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 either an ostial or non-ostial lesion with diameter stenosis > 50%, or
  • side branch requiring dilatation
  • Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:
  • 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. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  • Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
  • Lesion or vessel involves a myocardial bridge.
  • Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
  • Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
  • Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Treatment and study plan

ABSORB BVS

Device
  • Scaffold diameters: 2.5, 3.0 and 3.5 mm
  • Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
  • The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.

Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Xience

Device

Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).

  • Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
  • Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
  • For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices

To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Primary outcomes

  1. Number of Cardiac Death/TV-MI/ID-TLR (TLF)

    Time frame: 1 year

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Secondary outcomes

  1. Number of Participants With Powered Secondary Endpoint: Angina

    Time frame: 1 year

    Angina is defined as the first adverse event resulting in the site diagnosis of angina.

  2. Number of Participants With Powered Secondary Endpoint: All Revascularization

    Time frame: 1 year

    This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.

  3. Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)

    Time frame: 1 year

    This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.

  4. Acute Success- Device Success (Lesion Level Analysis)

    Time frame: On day 0 (the day of procedure)

    Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (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.

  5. Acute Success: Procedural Success (Subject Level Analysis)

    Time frame: On day 0 (the day of procedure)

    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 study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).

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

    Time frame: 0 to 5 years

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    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.

  7. Number of Participants With All Myocardial Infarction (MI)

    Time frame: 0 to 5 years

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  8. Number of Participants With All Target Lesion Revascularization (TLR)

    Time frame: 0 to 5 years

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

  9. Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)

    Time frame: 0 to 5 years

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  10. Number of Participants With All Revascularization

    Time frame: 0 to 5 years

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  11. Number of Death/All MI

    Time frame: 0 to 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

  12. Number of Cardiac Death/All MI

    Time frame: 0 to 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

  13. Number of Cardiac Death/TV-MI/ID-TLR (TLF)

    Time frame: 0 to 5 years

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  14. Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: 0 to 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).

  15. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 0 to 5 years

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

  16. Number of Death/All MI/All Revascularization (DMR)

    Time frame: 0 to 5 years

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

  17. Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)

    Time frame: ≤ 1 Day

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

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

    Time frame: 0 to 30 Days

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  19. Number of Participants With Subacute Stent/Scaffold Thrombosis

    Time frame: >1 to 30 Days

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

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

    Time frame: 31 to 365 Days

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

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

    Time frame: 366 to 393 Days

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  22. Number of Participants With Cumulative Stent/Scaffold Thrombosis

    Time frame: 0 to 1853 Days

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  23. Pre-Procedure Minimum Lumen Diameter (MLD)

    Time frame: < or = 1 day

    Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

  24. Pre-Procedure Percent Diameter Stenosis (%DS)

    Time frame: < or = 1 day

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

  25. Post-Procedure In-Segment Minimum Lumen Diameter (MLD)

    Time frame: ≤ 7 days post index procedure

    Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

    In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

  26. Post-Procedure In-Segment Percent Diameter Stenosis (%DS)

    Time frame: ≤ 7 days post index procedure

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

    In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

  27. Post-Procedure In-Device Minimum Lumen Diameter (MLD)

    Time frame: ≤ 7 days post index procedure

    Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

    In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold

  28. Post-Procedure In-Device Percent Diameter Stenosis (%DS)

    Time frame: ≤ 7 days post index procedure

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

  29. Post-Procedure In-Device Acute Gain

    Time frame: ≤ 7 days post index procedure

    The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

  30. Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)

    Time frame: From Post procedure to 3 Years

    • Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.
    • Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.

  31. Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)

    Time frame: 3 Years

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  32. Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal

    Time frame: 3 Years

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  33. Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area

    Time frame: 3 Years

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  34. Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area

    Time frame: 3 Years

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  35. Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts

    Time frame: 3 Years

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

Other outcomes

  1. Patient Reported Outcomes (PRO): Overall Health Status

    Time frame: Baseline

    Overall health status assessed using the EuroQoL 5D (EQ-5D™).

    EQ-5D:

    • Scale range: 0 to 1
    • Higher values represent better outcomes
    • Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.

    A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1

  2. Patient Reported Outcomes (PRO): Overall Health Status

    Time frame: 1 month

    Overall health status assessed using the EuroQoL 5D (EQ-5D™).

    EQ-5D:

    • Scale range: 0 to 1
    • Higher values represent better outcomes
    • Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.

    A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1

  3. Patient Reported Outcomes (PRO): Overall Health Status

    Time frame: 12 months

    Overall health status assessed using the EuroQoL 5D (EQ-5D™).

    EQ-5D:

    • Scale range: 0 to 1
    • Higher values represent better outcomes
    • Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.

    A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1

  4. Patient Reported Outcomes (PRO): Anxiety

    Time frame: Baseline

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

    GAD-7:

    • Scale range: 0 to 21
    • Lower values represent better outcomes
    • No subscales

  5. Patient Reported Outcomes (PRO): Anxiety

    Time frame: 1 month

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

    GAD-7:

    • Scale range: 0 to 21
    • Lower values represent better outcomes
    • No subscales

  6. Patient Reported Outcomes (PRO): Anxiety

    Time frame: 12 months

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

    GAD-7:

    • Scale range: 0 to 21
    • Lower values represent better outcomes
    • No subscales

  7. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life

    Time frame: Baseline

    Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ)

    Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

  8. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life

    Time frame: 1 month

    Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).

    Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

  9. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life

    Time frame: 12 months

    Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).

    Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

  10. Patient Reported Outcomes (PRO): Dyspnea Severity

    Time frame: Baseline

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).

    Rose Dyspnea Scale:

    • Scale range: 0 to 4
    • Lower values represent better outcomes (higher scores indicate worse dyspnea)
    • No subscales

  11. Patient Reported Outcomes (PRO): Dyspnea Severity

    Time frame: 1 month

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).

    Rose Dyspnea Scale:

    • Scale range: 0 to 4
    • Lower values represent better outcomes (higher scores indicate worse dyspnea)
    • No subscales

  12. Patient Reported Outcomes (PRO): Dyspnea Severity

    Time frame: 12 months

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).

    Rose Dyspnea Scale:

    • Scale range: 0 to 4
    • Lower values represent better outcomes (higher scores indicate worse dyspnea)
    • No subscales

  13. Landmark Analysis on TLF and Components

    Time frame: 3-4 years

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  14. Landmark Analysis on TLF and Components

    Time frame: 3-5 years

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  15. Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)

    Time frame: 3-4 years

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  16. Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)

    Time frame: 3-5 years

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: ABSORB-III

Important dates

Study start
2012
Primary completion
2016
Study completion
2020
First posted
Dec 18, 2012
Registry last updated
Oct 11, 2023

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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