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Completed

NCT Number: NCT01844284

AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population

Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nagoya Daini Red Cross Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.

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 20 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 or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
  • Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
  • Female subject of childbearing potential must not be pregnant* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.
  • Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
  • 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 13 months following the index procedure

Exclusion criteria

  • Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
  • Subject has known hypersensitivity or contraindication to device material and its degredants (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 had an acute myocardial infarction (AMI) within 72 hours of the index procedure
  • The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
  • Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (CK-MB) have not returned to within normal limits at the time of index procedure.
  • Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
  • Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
  • The target vessel was treated by PCI within 12 months.
  • Prior PCI within the non-target vessel 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.
  • 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, diabetes mellitus is not regarded as autoimmune disease.
  • Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  • Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
  • Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin 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 cirrhosis of Child-Pugh ≥ Class B.
  • Subject has known renal insufficiency;
  • Dialysis at the time of screening.
  • An estimated Glomerular filtration rate (GFR) < 30 ml/min/1.73m2
  • Subject is high risk of bleeding, or difficult to have appropriate treatment;
  • Has a history of bleeding diathesis or coagulopathy
  • Has had a significant gastro-intestinal or significant urinary bleed within the past six months
  • Has prior intracranial bleed
  • Has prior intracranial bleed (including severe permanent neurologic deficit that seem to be caused by previous intracranial bleeding)
  • Has known intracranial pathology that may cause intracranial bleeding per an investigator assessment (e.g. untreated aneurysm > 5 mm, arteriovenous malformation)
  • Subject will refuse blood transfusions
  • Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
  • Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  • Subject has life expectancy < 3 year.
  • 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.
  • Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write.

Treatment and study plan

XIENCE PRIME®/XIENCE Xpedition™

Device

Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

Absorb™ BVS

Device

Subjects receiving Absorb™ BVS

Primary outcomes

  1. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 1 year

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

Secondary outcomes

  1. Number of Participants With Any Death/Any MI/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

  2. Number of Participants With Any Death/Any MI/Revascularization (DMR)

    Time frame: 1 month

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

  3. Number of Participants With Any Death/Any MI/Revascularization (DMR)

    Time frame: 6 months

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

  4. Number of Participants With Any Death/Any MI/Revascularization (DMR)

    Time frame: 1 year

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

  5. Number of Participants With Any Death/Any MI/Revascularization (DMR)

    Time frame: 2 years

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

  6. Number of Participants With Any Death/Any MI/Revascularization (DMR)

    Time frame: 3 years

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

  7. Number of Participants With Any Death/Any MI/Revascularization (DMR)

    Time frame: 4 years

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

  8. Number of Participants With Any Death/Any MI/Revascularization (DMR)

    Time frame: 5 years

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

  9. Number of Participants With 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).

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

    Time frame: 1 month

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

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

    Time frame: 6 months

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

  12. Number of Participants With 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).

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

    Time frame: 2 years

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

  14. Number of Participants With 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).

  15. Number of Participants With 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).

  16. Number of Participants With 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).

  17. Number of Participants With Target Lesion Failure (TLF)

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

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

  18. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 1 month

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

  19. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 6 months

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

  20. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 2 years

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

  21. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 3 years

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

  22. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 4 years

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

  23. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 5 years

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

  24. Number of Participants With Cardiac Death/All MI

    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), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

  25. Number of Participants With Cardiac Death/All MI

    Time frame: 1 month

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

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

  26. Number of Participants With Cardiac Death/All MI

    Time frame: 6 months

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

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

  27. Number of Participants With Cardiac Death/All MI

    Time frame: 1 year

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

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

  28. Number of Participants With Cardiac Death/All MI

    Time frame: 2 years

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

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

  29. Number of Participants With Cardiac Death/All MI

    Time frame: 3 years

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

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

  30. Number of Participants With Cardiac Death/All MI

    Time frame: 4 years

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

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

  31. Number of Participants With Cardiac Death/All MI

    Time frame: 5 years

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

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

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

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

    Target Vessel Revascularization 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.

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

    Time frame: 1 month

    Target Vessel Revascularization 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.

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

    Time frame: 6 months

    Target Vessel Revascularization 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.

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

    Time frame: 1 year

    Target Vessel Revascularization 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.

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

    Time frame: 2 years

    Target Vessel Revascularization 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.

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

    Time frame: 3 years

    Target Vessel Revascularization 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.

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

    Time frame: 4 years

    Target Vessel Revascularization 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.

  39. Number of Participants With All Target Vessel Revascularization (TVR)

    Time frame: 5 years

    Target Vessel Revascularization 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.

  40. Number of Participants With Ischemia-driven TVR (ID-TVR)

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

    Target Vessel Revascularization 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.

  41. Number of Participants With Ischemia-driven TVR (ID-TVR)

    Time frame: 1 month

    Target Vessel Revascularization 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.

  42. Number of Participants With Ischemia-driven TVR (ID-TVR)

    Time frame: 6 months

    Target Vessel Revascularization 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.

  43. Number of Participants With Ischemia-driven TVR (ID-TVR)

    Time frame: 1 year

    Target Vessel Revascularization 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.

  44. Number of Participants With Ischemia-driven TVR (ID-TVR)

    Time frame: 2 years

    Target Vessel Revascularization 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.

  45. Number of Participants With Ischemia-driven TVR (ID-TVR)

    Time frame: 3 years

    Target Vessel Revascularization 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.

  46. Number of Participants With Ischemia-driven TVR (ID-TVR)

    Time frame: 4 years

    Target Vessel Revascularization 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.

  47. Number of Participants With Ischemia-driven TVR (ID-TVR)

    Time frame: 5 years

    Target Vessel Revascularization 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.

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

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

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

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

    Time frame: 1 month

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

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

    Time frame: 6 months

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

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

    Time frame: 1 year

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

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

    Time frame: 2 years

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

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

    Time frame: 3 years

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

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

    Time frame: 4 years

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

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

    Time frame: 5 years

    Target Lesion Revascularization 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 clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

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

  56. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

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

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  57. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

    Time frame: 1 month

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  58. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

    Time frame: 6 months

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  59. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

    Time frame: 1 year

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  60. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

    Time frame: 2 years

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  61. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

    Time frame: 3 years

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  62. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

    Time frame: 4 years

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  63. Number of Participants With Ischemia-driven Revascularization (ID-TLR)

    Time frame: 5 years

    A revascularization is considered ischemia-driven if associated with any of the following:

    • Positive functional ischemia study including positive FFR
    • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
    • Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

  64. Number of Participants Experiencing All 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 study 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.

  65. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    Time frame: 1 month

    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 study 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.

  66. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    Time frame: 6 months

    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 study 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.

  67. Number of Participants Experiencing All 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 study 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.

  68. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    Time frame: 2 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 study 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.

  69. Number of Participants Experiencing All 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 study 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.

  70. Number of Participants Experiencing All 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 study 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.

  71. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    Time frame: 5 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 study 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.

  72. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

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

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  73. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

    Time frame: 1 month

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  74. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

    Time frame: 6 months

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  75. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

    Time frame: 1 year

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  76. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

    Time frame: 2 years

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  77. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

    Time frame: 3 years

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  78. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

    Time frame: 4 years

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  79. Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))

    Time frame: 5 years

    • Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

  80. Number of Participants With Target Vessel MI (TV-MI)

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

  81. Number of Participants With Target Vessel MI (TV-MI)

    Time frame: 1 month

  82. Number of Participants With Target Vessel MI (TV-MI)

    Time frame: 6 months

  83. Number of Participants With Target Vessel MI (TV-MI)

    Time frame: 1 year

  84. Number of Participants With Target Vessel MI (TV-MI)

    Time frame: 2 years

  85. Number of Participants With Target Vessel MI (TV-MI)

    Time frame: 3 years

  86. Number of Participants With Target Vessel MI (TV-MI)

    Time frame: 4 years

  87. Number of Participants With Target Vessel MI (TV-MI)

    Time frame: 5 years

  88. Number of Participants With Stent/Scaffold Thrombosis

    Time frame: Acute (≤ 1 day)

    ITT population. Scaffold/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.

    Timings:

    • Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
    • Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
    • Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
    • Very late scaffold/stent thrombosis: >1 year post stent implantation

  89. Number of Participants With Stent/Scaffold Thrombosis

    Time frame: Subacute (>1 - 30 days)

    ITT population. Scaffold/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.

    Timings:

    • Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
    • Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
    • Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
    • Very late scaffold/stent thrombosis: >1 year post stent implantation

  90. Number of Participants With Stent/Scaffold Thrombosis

    Time frame: Late (31 - 365 days)

    ITT population. Scaffold/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.

    Timings:

    • Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
    • Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
    • Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
    • Very late scaffold/stent thrombosis: >1 year post stent implantation

  91. Number of Participants With Stent/Scaffold Thrombosis

    Time frame: Very Late (366 - 730 days)

    ITT population. Scaffold/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.

    Timings:

    • Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
    • Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
    • Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
    • Very late scaffold/stent thrombosis: >1 year post stent implantation

  92. Number of Participants With Stent/Scaffold Thrombosis

    Time frame: Very Late (731 - 1095 days)

    ITT population. Scaffold/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.

    Timings:

    • Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
    • Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
    • Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
    • Very late scaffold/stent thrombosis: >1 year post stent implantation

  93. Number of Participants With Stent/Scaffold Thrombosis

    Time frame: Very Late (1096 - 1460 days)

    ITT population. Scaffold/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.

    Timings:

    • Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
    • Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
    • Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
    • Very late scaffold/stent thrombosis: >1 year post stent implantation

  94. Number of Participants With Stent/Scaffold Thrombosis

    Time frame: Very Late (1461 - 1825 days)

    ITT population. Scaffold/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.

    Timings:

    • Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
    • Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
    • Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
    • Very late scaffold/stent thrombosis: >1 year post stent implantation

  95. In-segment Late Loss (Non-inferiority)

    Time frame: 13 months

  96. Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)

    Time frame: 2 years

    Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.

  97. Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation

    Time frame: 2 years

    Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.

    Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG)

  98. Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)

    Time frame: 2 years

    Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.

  99. Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)

    Time frame: 5 years

  100. Number of Participants With Not Ischemia-driven TLR (NID-TLR)

    Time frame: 5 years

  101. Number of Participants With Non-Target Vessel MI (NTV-MI)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population

Acronym: ABSORB JAPAN

Important dates

Study start
2013
Primary completion
2015
Study completion
2019
First posted
May 1, 2013
Registry last updated
Oct 8, 2020

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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