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Absorb IV Randomized Controlled Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT02173379
First received: June 9, 2014
Last updated: July 13, 2017
Last verified: July 2017
  Purpose

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. 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.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.


Condition Intervention
Coronary Artery Disease Coronary Artery Stenosis Coronary Disease Coronary Stenosis Device: Absorb BVS Device: XIENCE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Powered Target lesion failure (TLF) tested for non-inferiority of Absorb BVS to XIENCE. [ Time Frame: 30 days ]
    This analysis will consist of ~2610 subjects in ABSORB IV.

  • Landmark Target lesion failure (TLF) [ Time Frame: Between 3 and 7 years (time from 3 year to the first TLF between 3 and 7 years) ]
    • TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR).
    • This analysis will consist of ~4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV).


Secondary Outcome Measures:
  • Powered TLF, tested for non-inferiority of Absorb BVS to XIENCE [ Time Frame: 1 year ]
    This analysis will consist of ~2610 subjects in ABSORB IV.

  • Angina Powered Secondary Endpoint [ Time Frame: 1 year ]
    • The percentage of patients who experienced angina within 1 year, tested first for non-inferiority with reflex to superiority against the control.
    • Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
    • This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
    • For subjects who receive a planned staged procedure to treat one or more target lesions, the analysis will exclude angina or angina equivalent symptoms that occurred following the original index procedure through hospital discharge or 7 days after the final procedure, whichever occurs first.
    • This analysis will consist of ~2610 subjects in ABSORB IV.

  • Acute Success- Device success (Lesion level analysis) [ Time Frame: on day 0 ]
    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.

  • Acute Success- Procedural success (Subject level analysis) [ Time Frame: on day 0 ]
    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).

  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: Approximately 7 days (in-hospital) ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 30 days ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 90 days ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 180 days ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 270 days ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 1 year ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 2 years ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 3 years ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 4 years ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 5 years ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 6 years ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 7 years ]

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

    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.


  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Myocardial Infarction (MI) [ Time Frame: Approximately 7 days (in-hospital) ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 30 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 90 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 180 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 270 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 1 year ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 2 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 3 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 4 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 5 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 6 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 7 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction (MI) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Myocardial Infarction (MI) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Myocardial Infarction (MI) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Lesion Revascularization (TLR) [ Time Frame: Approximately 7 days (in-hospital) ]
    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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 30 days ]
    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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 90 days ]
    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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 180 days ]
    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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 270 days ]
    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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 1 year ]
    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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 2 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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 3 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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 4 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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 6 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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 7 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 or not ischemia driven by the investigator prior to repeat angiography.

  • Target Lesion Revascularization (TLR) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Lesion Revascularization (TLR) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Lesion Revascularization (TLR) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Vessel Revascularization (TVR) [ Time Frame: Approximately 7 days ]

    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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 30 days ]

    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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 90 days ]

    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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 180 days ]
    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. classified as: Ischemic driven TVR and Non-ischemic driven TVR.

  • Target Vessel Revascularization (TVR) [ Time Frame: 270 days ]

    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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 1 year ]

    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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 2 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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 3 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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 4 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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 6 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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 7 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.

    -TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.


  • Target Vessel Revascularization (TVR) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Vessel Revascularization (TVR) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Vessel Revascularization (TVR) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • All coronary revascularization [ Time Frame: Approximately 7 days (in-hospital) ]
  • All coronary revascularization [ Time Frame: 30 days ]
  • All coronary revascularization [ Time Frame: 90 days ]
  • All coronary revascularization [ Time Frame: 180 days ]
  • All coronary revascularization [ Time Frame: 270 days ]
  • All coronary revascularization [ Time Frame: 1 year ]
  • All coronary revascularization [ Time Frame: 2 years ]
  • All coronary revascularization [ Time Frame: 3 years ]
  • All coronary revascularization [ Time Frame: 4 years ]
  • All coronary revascularization [ Time Frame: 5 years ]
  • All coronary revascularization [ Time Frame: 6 years ]
  • All coronary revascularization [ Time Frame: 7 years ]
  • All coronary revascularization [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • All coronary revascularization [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • All coronary revascularization [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death/All MI [ Time Frame: Approximately 7 days (in-hospital) ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 30 days ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 90 days ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 180 days ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 270 days ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 1 year ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 2 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: 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.


  • Death/All MI [ Time Frame: 3 years ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 4 years ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 5 years ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    -Non-Q wave MI: 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.


  • Death/All MI [ Time Frame: 6 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: 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.


  • Death/All MI [ Time Frame: 7 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: 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.


  • Death/All MI [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death/All MI [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death/All MI [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI [ Time Frame: Approximately 7 days (in-hospital) ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 30 days ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 90 days ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 180 days ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 270 days ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 1 year ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 2 years ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 3 years ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 4 years ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 5 years ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 6 years ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 7 years ]
    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

  • Cardiac Death/All MI [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: Approximately 7 days (in-hospital) ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 30 days ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 90 days ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 180 days ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 270 days ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 1 year ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 2 years ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 3 years ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 4 years ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 5 years ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 6 years ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 7 years ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [ Time Frame: Approximately 7 days (in-hospital) ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 30 days ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 90 days ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 180 days ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 270 days ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 1 year ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 2 years ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 3 years ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 4 years ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 5 years ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 6 years ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 7 years ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: Approximately 7 days (in-hospital) ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 30 days ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 90 days ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 180 days ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 270 days ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 1 year ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 2 years ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 3 years ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 4 years ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 5 years ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 6 years ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 7 years ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death/All MI/All revascularization (DMR) [ Time Frame: Approximately 7 days (in-hospital) ]
  • Death/All MI/All revascularization [ Time Frame: 30 days ]
  • Death/All MI/All revascularization [ Time Frame: 90 days ]
  • Death/All MI/All revascularization [ Time Frame: 180 days ]
  • Death/All MI/All revascularization [ Time Frame: 270 days ]
  • Death/All MI/All revascularization [ Time Frame: 1 year ]
  • Death/All MI/All revascularization [ Time Frame: 2 years ]
  • Death/All MI/All revascularization [ Time Frame: 3 years ]
  • Death/All MI/All revascularization [ Time Frame: 4 years ]
  • Death/All MI/All revascularization [ Time Frame: 5 years ]
  • Death/All MI/All revascularization [ Time Frame: 6 years ]
  • Death/All MI/All revascularization [ Time Frame: 7 years ]
  • Death/All MI/All revascularization [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death/All MI/All revascularization [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Death/All MI/All revascularization [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Scaffold/Stent Thrombosis (per Academic Research Consortium (ARC) definition) [ Time Frame: Acute (0 - 24 hours post stent implantation) ]
    Definite and Probable

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: Subacute (>24 hours - 30 days post stent implantation) ]
    Definite and Probable

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: Late (30 days - 1 year post stent implantation) ]
    Definite and Probable

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: Very late (>1 year post stent implantation) ]
    Definite and Probable

  • Rehospitalization [ Time Frame: 30 days ]
    • Coronary artery disease (CAD) related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 90 days ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 180 days ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 270 days ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 1 year ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 2 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 3 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 4 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 5 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 6 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 7 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Rehospitalization [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Rehospitalization [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Repeat coronary arteriography [ Time Frame: Approximately 7 days (in-hospital) ]
  • Repeat coronary arteriography [ Time Frame: 30 days ]
  • Repeat coronary arteriography [ Time Frame: 90 days ]
  • Repeat coronary arteriography [ Time Frame: 180 days ]
  • Repeat coronary arteriography [ Time Frame: 270 days ]
  • Repeat coronary arteriography [ Time Frame: 1 year ]
  • Repeat coronary arteriography [ Time Frame: 2 years ]
  • Repeat coronary arteriography [ Time Frame: 3 years ]
  • Repeat coronary arteriography [ Time Frame: 4 years ]
  • Repeat coronary arteriography [ Time Frame: 5 years ]
  • Repeat coronary arteriography [ Time Frame: 6 years ]
  • Repeat coronary arteriography [ Time Frame: 7 years ]
  • Repeat coronary arteriography [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Repeat coronary arteriography [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Repeat coronary arteriography [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on TLF and components [ Time Frame: 3-4 years ]
  • Landmark analysis on TLF and components [ Time Frame: 3-5 years ]
  • Landmark analysis on TLF and components [ Time Frame: 3-6 years ]
  • Landmark analysis on TLF and components [ Time Frame: 3-8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on TLF and components [ Time Frame: 3-9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on TLF and components [ Time Frame: 3-10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on MACE and TVF and their components [ Time Frame: 3-4 years ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 3-5 years ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 3-6 years ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 3-7 years ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 3-8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on MACE and TVF and their components [ Time Frame: 3-9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on MACE and TVF and their components [ Time Frame: 3-10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 3-4 years ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 3-5 years ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 3-6 years ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 3-7 years ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 3-8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 3-9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 3-10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Lesion Failure (TLF) [ Time Frame: 1 year ]
    The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)

  • Target Lesion Failure (TLF) [ Time Frame: 7 years ]
    The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)

  • Target Lesion Failure (TLF) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Lesion Failure (TLF) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  • Target Lesion Failure (TLF) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.


Other Outcome Measures:
  • Patient Reported Outcomes (PRO) [ Time Frame: Baseline ]

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.


  • Patient Reported Outcomes (PRO) [ Time Frame: 1 month ]

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.


  • Patient Reported Outcomes (PRO) [ Time Frame: 6 months ]

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.


  • Patient Reported Outcomes (PRO) [ Time Frame: 1 year ]

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.


  • Patient Reported Outcomes (PRO) [ Time Frame: 3 years ]

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.


  • Patient Reported Outcomes (PRO) [ Time Frame: 5 years ]

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.



Enrollment: 2610
Actual Study Start Date: July 2014
Estimated Study Completion Date: April 2024
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Absorb BVS
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Device: Absorb BVS
  • Scaffold diameters: 2.5, 3.0 and 3.5 mm
  • Scaffold lengths: 8, 12, 18, and 28 mm. 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.
  • Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.
  • 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.

Active Comparator: XIENCE
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
Device: XIENCE

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. The 3.25 mm is only available for XIENCE Xpedition
  • Stent lengths: 8, 12, 15, 18, 23, and 28 mm
  • 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.


Detailed Description:

ABSORB IV:

A. Primary Objective:

  • To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
  • To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

B. Secondary Objectives:

  • To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
  • To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.

The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4, 5, 6 and 7 years.

Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
  3. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:

    1. Unstable angina or NSTEMI within 2 weeks of the index procedure.
    2. STEMI > 72 hours ≤ 2 weeks prior to the index procedure.

    Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

  4. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).

    (Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)

  5. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  6. 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.
  7. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.
  8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.

Angiographic Inclusion Criteria:

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.

1. 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 thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).

  1. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
  2. Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.
  2. 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.
  3. Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.
  5. Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:

    1. Subject requires coumadin or any other agent for chronic oral anticoagulation.
    2. Subject is likely to become hemodynamically unstable due to their arrhythmia.
    3. Subject has poor survival prognosis due to their arrhythmia.
  6. 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 acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.
  7. 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 a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
  8. Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions < 30 days after the index procedure.
  9. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  10. At the time of screening, the subject has a malignancy that is not in remission.
  11. 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.
  12. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  13. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).
  14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  15. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  16. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
  17. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.
  18. 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.).
  19. 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.
  20. Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.
  21. 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.
  22. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  23. 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 a 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).

  1. Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):

    1. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
    2. TIMI flow grade <3 (per visual estimation).
    3. Any angiographic complication (e.g. distal embolization, side branch closure).
    4. Any dissection NHLBI grade D-F.
    5. Any chest pain lasting > 5 minutes.
    6. Any ST-segment depression or elevation lasting > 5 minutes.
  2. Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
  3. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
  4. Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).
  5. Lesion involving a bifurcation with a:

    1. side branch ≥ 2 mm in diameter, or
    2. side branch with either an ostial or non-ostial lesion with diameter stenosis >50%, or
    3. side branch requiring dilatation
  6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:

    1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
    2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
    3. Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  7. Lesion or vessel involves a myocardial bridge.
  8. Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.
  9. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02173379

  Show 150 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Study Chair: Gregg W Stone, MD Columbia University Medical Center, New York, NY
Principal Investigator: Gregg W Stone, MD Columbia University Medical Center, New York, NY
Principal Investigator: Stephen G Ellis, MD Cleveland Clinic, Cleveland OH
Principal Investigator: Dean J Kereiakes, MD The Christ Hospital, Cincinnati, OH
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT02173379     History of Changes
Other Study ID Numbers: 10-392 C
Study First Received: June 9, 2014
Last Updated: July 13, 2017

Keywords provided by Abbott Vascular:
Absorb™ BVS
Angioplasty
Bioabsorbable
BVS
Coronary Artery Disease
Coronary Artery Endothelial Responsiveness
Coronary artery restenosis
Coronary artery stenosis
Coronary scaffold
Coronary Stent
Drug eluting stents
Everolimus
Myocardial ischemia
Stent thrombosis
Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 17, 2017