Absorb IV Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT02173379
First received: June 9, 2014
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 3000 subjects at approximately 140 sites. 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:
  • Angina Primary Endpoint: The percentage of patients who experienced angina within 1 year, tested first for non-inferiority with reflex to superiority against the control. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • 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 ~3000 subjects in ABSORB IV.

  • Landmark TLF Primary Endpoint: TLF between 1 and 5 years, tested first for non-inferiority (NI) of Absorb BVS to XIENCE with reflex testing to superiority. [ Time Frame: Between 1 and 5 years ] [ Designated as safety issue: Yes ]
    • 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 ~5000 subjects (2000 primary analysis subjects of ABSORB III and 3000 subjects of ABSORB IV).


Secondary Outcome Measures:
  • Powered Secondary Outcome: TLF through 1 year, tested for non-inferiority of Absorb BVS to XIENCE. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    This analysis will consist of ~3000 subjects in ABSORB IV.

  • Acute Success- Device success (Lesion level analysis) [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
    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: Intraoperative ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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.


  • Myocardial Infarction (MI) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

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

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

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

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

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

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

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

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

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

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Lesion Revascularization (ID-TLR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TLR (NID-TLR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Ischemia driven-Target Vessel Revascularization (ID-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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.

  • Non ID-TVR (NID-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.

  • All coronary revascularization [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death/All MI [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Death/All MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  • Cardiac Death/All MI [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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/TV-MI/ID-TLR (TLF) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: Approximately 7 days ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: Acute (0 - 24 hours post stent implantation) ] [ Designated as safety issue: Yes ]
    Definite and Probable

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

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

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

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

  • Rehospitalization [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Rehospitalization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  • Repeat coronary arteriography [ Time Frame: Approximately 7 days ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 270 days ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Repeat coronary arteriography [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Landmark analysis on TLF and components [ Time Frame: 1-2 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on TLF and components [ Time Frame: 1-3 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on TLF and components [ Time Frame: 1-4 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on TLF and components [ Time Frame: 1-5 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 1-2 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 1-3 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 1-4 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on MACE and TVF and their components [ Time Frame: 1-5 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 1-2 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 1-3 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 1-4 years ] [ Designated as safety issue: Yes ]
  • Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable) [ Time Frame: 1-5 years ] [ Designated as safety issue: Yes ]
  • TLF through 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Based on 5000 subjects-2000 primary analysis subjects of ABSORB III and 3000 subjects of ABSORB IV

  • TLF through 5 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Based on 5000 subjects-2000 primary analysis subjects of ABSORB III and 3000 subjects of ABSORB IV


Other Outcome Measures:
  • Patient Reported Outcomes (PRO) [ Time Frame: Approximately 7 days ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization

  • Patient Reported Outcomes (PRO) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization

  • Patient Reported Outcomes (PRO) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization

  • Patient Reported Outcomes (PRO) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization

  • Patient Reported Outcomes (PRO) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization

  • Patient Reported Outcomes (PRO) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization

  • Patient Reported Outcomes (PRO) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization

  • Patient Reported Outcomes (PRO) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
    • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    The PROs will be analyzed for the following:

    • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
    • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization


Estimated Enrollment: 3000
Study Start Date: July 2014
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Absorb BVS
Subjects receiving Absorb 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.

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 and XIENCE Xpedition.

  • 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.

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

The enrollment of the 3000 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, and 5 years, potentially at 6 and/or 7 years if it is necessary as determined by the Sponsor. In addition, all 3000 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30, 90, 180, 270 days, and annually through 3 years.

The ABSORB IV trial will also include an imaging ischemia sub-study which will provide the physiological and mechanistic evaluation of whether percutaneous coronary intervention (PCI) treatment with Absorb compared to XIENCE results in differences in myocardial ischemia in the early post-procedural period, and at 14 months and 62 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 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. Patients 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 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

  1. Treatment of up to three target de novo lesion in a maximum of two epicardial vessels, with a maximum of two target lesions per epicardial 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 should be considered a single target lesion for lesion (and stent) length determination and must be treated with a single study device.
  2. 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 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 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.

General Exclusion Criteria

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 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 during the last 12 months.
  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 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 < 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):

    • Residual %DS after pre-dilatation is > 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
    • TIMI flow grade <3 (per visual estimation).
    • Any angiographic complication (e.g. distal embolization, side branch closure).
    • Any dissection National Heart Lung and Blood Institute (NHLBI) grade D-F.
    • Any chest pain lasting > 5 minutes.
    • 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.
  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

Contacts
Contact: Vicki Gashwiler 406-544-5201 victoria.gashwiler@av.abbott.com

Locations
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
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

No publications provided

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: September 18, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014