ABSORB III Randomized Controlled Trial (RCT) (ABSORB-III)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01751906
First received: December 13, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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

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


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.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) at 1 year, non-inferiority (NI) against the control. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

    Sample size of 1900 subjects is required for the study (2:1 randomization); 1267 subjects for Absorb BVS arm and 633 subjects for XIENCE arm. Assuming a 5% dropout rate approximately 2,000 subjects will be required

    The ABSORB III primary endpoint of TLF at 1-year follow up will be analyzed for the ITT and the PTE populations. The primary analysis will be based on the ITT population. The non-inferiority hypothesis testing will be performed using a non-inferiority test statistic by Farrington and Manning. Non-inferiority of Absorb BVS to XIENCE will be established if the p-value for the non-inferiority test is less than 0.025.



Secondary Outcome Measures:
  • Powered Imaging Cohort Secondary Endpoint: The in-stent/scaffold mean lumen diameter change, between pre- and post-nitrate infusion at 3 years by angiography [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
    Pooled angiographic subjects (~600 subjects): 200 subjects from the Imaging Cohort of ABSORB III and 400 subjects from the ABSORB Japan RCT.

  • Powered Imaging Cohort Secondary Endpoint: The in-stent/scaffold mean lumen diameter change, between pre- and post-nitrate infusion at 3 years by angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Pooled angiographic subjects (~600 subjects): 200 subjects from the Imaging Cohort of ABSORB III and 400 subjects from the ABSORB Japan RCT.

  • Powered Imaging Cohort Secondary Endpoint: The in-stent/scaffold mean lumen area change, from post-procedure to 3 years by intravascular ultrasound (IVUS) [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
    • Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.
    • Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.

  • Powered Imaging Cohort Secondary Endpoint: The in-stent/scaffold mean lumen area change, from post-procedure to 3 years by IVUS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.
    • Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.

  • Powered Secondary Endpoint: Site Diagnosed Angina (SDA) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    This powered secondary endpoint is intended to assess site diagnosed angina (SDA) at 1 year and test for superiority of Absorb BVS to XIENCE.

    • SDA is defined as the first adverse event resulting in the site diagnosis of angina.
    • The analysis will exclude site diagnosed angina following the index procedure through discharge, not to exceed a period of 7 days.

    This analysis will include ~2000 subjects.


  • Powered Secondary Endpoint: Diabetic Indication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The powered secondary endpoint will be to support a diabetic indication for Absorb BVS.

  • Acute Success- Device success (Lesion level analysis) [ Time Frame: From the start of index procedure to end of index procedure ] [ 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 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: From the start of index procedure to end of index procedure ] [ 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 180 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ 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: 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: 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: During hospital stay ] [ 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: 180 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: During hospital stay ] [ 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: 180 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: During hospital stay ] [ 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: 180 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: During hospital stay ] [ 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: 180 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: During hospital stay ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Timing (acute, sub-acute, late and very late)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: During hospital stay ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • Scaffold/Stent Thrombosis (per ARC definition) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Evidence (Definite, Probable and Possible)

  • 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 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 ]
  • Optical Coherence Tomography (OCT) endpoint [ Time Frame: Post-procedure ] [ Designated as safety issue: Yes ]

    All OCT endpoints will be collected for within the device and within the treated segment:

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


  • Optical Coherence Tomography (OCT) endpoint [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    All OCT endpoints will be collected for within the device and within the treated segment:

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



Other Outcome Measures:
  • Patient Reported Outcomes (PRO) [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

  • Patient Reported Outcomes (PRO) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

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

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

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

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

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

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

  • Patient Reported Outcomes (PRO) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

  • Patient Reported Outcomes (PRO) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety


Estimated Enrollment: 2250
Study Start Date: December 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2015 (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 The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.

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

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 III RCT:

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

B. Powered Secondary Objectives:

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

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

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

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

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. 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. In the absence of noninvasive ischemia, FFR must be done and indicative of ischemia.
  4. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. 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.
  6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
  7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an adenosine diphosphate (ADP) antagonist is planned within 12 months after the procedure.
  2. 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. Allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  4. Acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
  5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  6. Cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:

    (NOTE: Investigator should use discretion when enrolling subjects with high CHADS scores)

    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
  7. Left ventricular ejection fraction (LVEF) < 30%.
  8. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
  9. Future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure.
  10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  11. At the time of screening, the subject has a malignancy that is not in remission.
  12. 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.
  13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
  15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  17. Renal insufficiency. NOTE: Estimated GFR can be based on Modification of Diet in Renal Disease (MDRD) equation or Cockcroft-Gault equation (CCG).
  18. High risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  19. 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.).
  20. 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.
  21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
  22. 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.
  23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  24. Vulnerable population.

Angiographic Inclusion Criteria:

  1. One or two de novo target lesions:

    1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
    2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
    3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
  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 TIMI flow of ≥1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress test), unstable angina or post-infarct angina.

    1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤ 3.75 mm.
    2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
    3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

Angiographic Exclusion Criteria:

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

  1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

    1. Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
    2. TIMI Grade-3 flow (per visual estimation).
    3. No angiographic complications (e.g. distal embolization, side branch closure).
    4. No dissections NHLBI grade D-F.
    5. No chest pain lasting > 5 minutes.
    6. No ST depression or elevation lasting > 5 minutes
  2. Lesion is located in left main.
  3. Aorto-ostial RCA lesion (within 3 mm of the ostium).
  4. Lesion located within 3 mm of the origin of the LAD or 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 IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
  8. Lesion or vessel involves a myocardial bridge.
  9. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
  10. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
  11. 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: NCT01751906

Contacts
Contact: Diane Williams 408 845-3000 AbsorbRCT@abbott.com

  Show 223 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Stephen G Ellis, MD Cleveland Clinic, Cleveland OH
Principal Investigator: Dean J Kereiakes, MD The Christ Hospital, Cincinnati, OH
Study Chair: Gregg W Stone, MD Columbia University Medical Center, New York, NY
Study Director: Peter Staehr, MD Abbott Vascular
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01751906     History of Changes
Other Study ID Numbers: 10-392
Study First Received: December 13, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014