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

  Hide Study Locations
Locations
United States, Alabama
Baptist Medical Center Princeton Active, not recruiting
Birmingham, Alabama, United States, 35211
University of Alabama Hospital Recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Massoud Leesar, M.D.         
Thomas Hospital Active, not recruiting
Fairhope, Alabama, United States, 36532
Baptist Medical Center South Recruiting
Montgomery, Alabama, United States, 36117
Principal Investigator: Narinder Bhalla, M.D.         
United States, Arizona
Chandler Regional Medical Center Recruiting
Gilbert, Arizona, United States, 85297
Principal Investigator: Nabil Dib, M.D.         
Banner Heart Hospital Active, not recruiting
Mesa, Arizona, United States, 85206
Banner Good Samaritan Medical Center Active, not recruiting
Phoenix, Arizona, United States, 85006
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85260
Principal Investigator: David Rizik, M.D.         
United States, Arkansas
Arkansas Heart Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72211
United States, California
John Muir Medical Center - Concord Campus Recruiting
Concord, California, United States, 94520
Principal Investigator: Gary Gershony, M.D.         
Washington Hospital Recruiting
Fremont, California, United States, 94538
Principal Investigator: Ashit Jain, M.D.         
Scripps Green Hospital Active, not recruiting
La Jolla, California, United States, 92037
Scripps Memorial Hospital Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Richard Fortuna, M.D.         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90043
Principal Investigator: Rajendra Makkar, M.D.         
Good Samaritan Hospital Active, not recruiting
Los Angeles, California, United States, 90017
Ronald Regan UCLA Medical Center Withdrawn
Los Angeles, California, United States, 90095
Sutter Central Valley Hospitals dba Memorial Medical Center Active, not recruiting
Modesto, California, United States, 95355
Eisenhower Medical Center, Desert Cardiology Center Withdrawn
Rancho Mirage, California, United States, 92270
UC Davis Medical Center Active, not recruiting
Sacramento, California, United States, 95817
Mercy General Hospital Active, not recruiting
Sacramento, California, United States, 95816
Sutter Memorial Hospital Active, not recruiting
Sacramento, California, United States, 95819
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Principal Investigator: John Gordon, M.D.         
Santa Barbara Cottage Hospital Active, not recruiting
Santa Barbara, California, United States, 93105
Stanford Hospital and Clinics Active, not recruiting
Stanford, California, United States, 94305
Little Company Of Mary Hospital Active, not recruiting
Torrance, California, United States, 90503
Torrance Memorial Medical Center Active, not recruiting
Torrance, California, United States, 90505
United States, Colorado
University of Colorado Hospital Withdrawn
Aurora, Colorado, United States, 80045
Memorial Hospital Active, not recruiting
Colorado Springs, Colorado, United States, 80909
Medical Center of the Rockies Active, not recruiting
Fort Collins, Colorado, United States, 80538
United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Michael Cleman, M.D.         
St. Vincent's Medical Center Active, not recruiting
Stamford, Connecticut, United States, 06905
United States, Delaware
Christiana Care Health Services Active, not recruiting
Newark, Delaware, United States, 19718
United States, Florida
Brandon Regional Hospital Active, not recruiting
Brandon, Florida, United States, 33511
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Principal Investigator: Patrick Cambier, M.D.         
Holy Cross Hospital Active, not recruiting
Fort Lauderdale, Florida, United States, 33308
Memorial Regional Hospital Active, not recruiting
Hollywood, Florida, United States, 33021
St. Vincent's Medical Center Active, not recruiting
Jacksonville, Florida, United States, 32204
Baptist Medical Center - Downtown Active, not recruiting
Jacksonville, Florida, United States, 32207
University of Florida UF Health Active, not recruiting
Jacksonville, Florida, United States, 32209
Baptist Hospital of Miami Active, not recruiting
Miami, Florida, United States, 33176
University of Miami Hospital Active, not recruiting
Miami, Florida, United States, 33136
Munroe Regional Medical Center Active, not recruiting
Ocala, Florida, United States, 34471
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: Andrew Taussig, M.D.         
Palm Beach Gardens Medical Center Active, not recruiting
Palm Beach Gardens, Florida, United States, 33410
Bay County Health Systems Active, not recruiting
Panama City, Florida, United States, 32401
Baptist Hospital Active, not recruiting
Pensacola, Florida, United States, 32501
Tallahassee Memorial Hospital Active, not recruiting
Tallahassee, Florida, United States, 32308
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33609
Principal Investigator: Fadi Matar, M.D.         
Florida Hospital Pepin Heart Institute Active, not recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Saint Joseph's Hospital of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: William Lieppe, M.D.         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Habib Samady, M.D.         
Emory Hospital-Midtown Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Habib Samady, M.D.         
Piedmont Hospital Active, not recruiting
Atlanta, Georgia, United States, 30309
University Hospital Active, not recruiting
Augusta, Georgia, United States, 30901
Northeast Georgia Medical Center Active, not recruiting
Gainesville, Georgia, United States, 30501
Medical Center of Central Georgia Withdrawn
Macon, Georgia, United States, 31201
Wellstar Kennestone Hospital Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern Memorial Hospital Active, not recruiting
Chicago, Illinois, United States, 60611
Loyola University Medical Center Withdrawn
Maywood, Illinois, United States, 60153
Advocate Christ Medical Center Active, not recruiting
Oak Lawn, Illinois, United States, 60453
Saint Francis Medical Center Active, not recruiting
Peoria, Illinois, United States, 61614
St. John's Hospital Active, not recruiting
Springfield, Illinois, United States, 62701
United States, Indiana
Elkhart General Healthcare Active, not recruiting
Elkhart, Indiana, United States, 46514
Methodist Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46202
St. Vincent Heart Center of Indiana Active, not recruiting
Indianapolis, Indiana, United States, 46290
Franciscan St. Francis Health Active, not recruiting
Indianapolis, Indiana, United States, 46237
United States, Iowa
Genesis Medical Center Active, not recruiting
Davenport, Iowa, United States, 52803
Mercy Medical Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
The University of Kansas Hospital and Medical Center Active, not recruiting
Kansas City, Kansas, United States, 66106
United States, Kentucky
University of Kentucky Medical Center Active, not recruiting
Lexington, Kentucky, United States, 40536
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Principal Investigator: Michael Jones, M.D.         
Norton Audubon Hospital Withdrawn
Louisville, Kentucky, United States, 40205
Jewish Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Terrebonne General Medical Center Withdrawn
Houma, Louisiana, United States, 70360
Ochsner Clinic Foundation Withdrawn
New Orleans, Louisiana, United States, 70121
Willis Knighton Medical Center Withdrawn
Shreveport, Louisiana, United States, 71105
United States, Maine
Eastern Maine Medical Center Active, not recruiting
Bangor, Maine, United States, 04401
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Principal Investigator: Thomas Ryan, Jr., M.D.         
United States, Maryland
The Johns Hopkins Hospital Withdrawn
Baltimore, Maryland, United States, 21287
MedStar Washington Hospital Center Recruiting
Hyattsville, Maryland, United States, 20782
Principal Investigator: Ron Waksman, M.D.         
Union Memorial Hospital Active, not recruiting
Hyattsville, Maryland, United States, 20782
Peninsula Regional Medical Center Active, not recruiting
Salisbury, Maryland, United States, 21804
Washington Adventist Hospital Active, not recruiting
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Brigham and Women's Hospital Active, not recruiting
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Withdrawn
Boston, Massachusetts, United States, 02114
Boston University Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
St. Elizabeth's Medical Center of Boston Active, not recruiting
Brighton, Massachusetts, United States, 02135
UMass Memorial Medical Center Active, not recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Bay Regional Medical Center Active, not recruiting
Bay City, Michigan, United States, 48708
Oakwood Hospital and Medical Center Active, not recruiting
Dearborn, Michigan, United States, 48124
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
Harper University Hospital Active, not recruiting
Detroit, Michigan, United States, 48201
St. John Hospital & Medical Center Active, not recruiting
Detroit, Michigan, United States, 48236
Spectrum Health Withdrawn
Grand Rapids, Michigan, United States, 49503
Borgess Medical Center Active, not recruiting
Kalamazoo, Michigan, United States, 49048
Sparrow Hospital Active, not recruiting
Lansing, Michigan, United States, 48910
Northern Michigan Hospital Recruiting
Petoskey, Michigan, United States, 49770
Principal Investigator: Louis Cannon, M.D.         
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48703
Principal Investigator: Amr Abbas, M.D.         
Munson Medical Center Active, not recruiting
Traverse City, Michigan, United States, 49684
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Principal Investigator: Herbert D. Aronow, M.D.         
United States, Minnesota
Abbott Northwestern Hospital Active, not recruiting
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Center Active, not recruiting
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Withdrawn
Rochester, Minnesota, United States, 55905
United States, Mississippi
North Mississippi Medical Center Cardiology Associates Research, LLC Active, not recruiting
Tupelo, Mississippi, United States, 38801
United States, Missouri
Boone Hospital Center Recruiting
Columbia, Missouri, United States, 65201
Principal Investigator: Anthony Spaedy, M.D.         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65807
Principal Investigator: Robert Merritt, M.D.         
Barnes Jewish Hospital Active, not recruiting
St. Louis, Missouri, United States, 63110
St. Anthony's Medical Center Active, not recruiting
St. Louis, Missouri, United States, 63129
United States, Montana
St. Patrick Hospital Active, not recruiting
Missoula, Montana, United States, 59802
United States, Nebraska
Nebraska Heart Hospital Active, not recruiting
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator: Aaron Kaplan, M.D.         
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Principal Investigator: Joseph DeGregorio, M.D.         
Cooper University Hospital Active, not recruiting
Haddon Heights, New Jersey, United States, 08035
Our Lady of Lourdes Medical Center Recruiting
Haddon Heights, New Jersey, United States, 08035
Principal Investigator: Vijayendra Verma, M.D.         
Morristown Medical Center Active, not recruiting
Morristown, New Jersey, United States, 07962
Jersey Shore University Medical Center Active, not recruiting
Neptune, New Jersey, United States, 07753
St. Joseph's Regional Medical Center Active, not recruiting
Paterson, New Jersey, United States, 07503
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Principal Investigator: Arvind Agarwal, M.D.         
United States, New Mexico
Presbyterian Hospital Active, not recruiting
Albuquerque, New Mexico, United States, 87106
Heart Hospital New Mexico Withdrawn
Albuquerque, New Mexico, United States, 87102
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Principal Investigator: Vankeepuram Srinivas, M.D.         
St. Joseph's Hospital Health Center Recruiting
Liverpool, New York, United States, 13088
Principal Investigator: Ronald Caputo, M.D.         
Long Island Jewish Medical Center Active, not recruiting
Manhasset, New York, United States, 11030
Winthrop University Hospital Active, not recruiting
Mineola, New York, United States, 11501
Lenox Hill Hospital Active, not recruiting
New York, New York, United States, 10075
Mount Sinai Medical Center Active, not recruiting
New York, New York, United States, 10029
NYU Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
New York Presbyterian Hospital-Cornell University Recruiting
New York, New York, United States, 10065
Principal Investigator: Shing C Wong, M.D.         
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Strong Memorial Hospital Active, not recruiting
Rochester, New York, United States, 14627
Rochester General Hospital Active, not recruiting
Rochester, New York, United States, 14621
St. Francis Hospital Withdrawn
Roslyn, New York, United States, 11576
Stony Brook University Medical Center Active, not recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Presbyterian Hospital Active, not recruiting
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28203
Carolinas Medical Center - Pineville Active, not recruiting
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27110
Rex Hospital Recruiting
Raleigh, North Carolina, United States, 27607
Principal Investigator: James Zidar, M.D.         
WakeMed Recruiting
Raleigh, North Carolina, United States, 27610
Principal Investigator: William Newman, M.D.         
Novant Health Forsyth Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Baptist Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Aultman Hospital Active, not recruiting
Canton, Ohio, United States, 44710
The Christ Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45219
Tri-Health Good Samaritan Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45242
University Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45206
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
University Hospitals of Cleveland Active, not recruiting
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
Ohio State University Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
EMH Healthcare Active, not recruiting
Elyria, Ohio, United States, 44035
Cleveland Cln Fairview Hospital Active, not recruiting
Fairview Park, Ohio, United States, 44126
Kettering Medical Center Active, not recruiting
Kettering, Ohio, United States, 45429
Mercy St. Vincent's Medical Center Active, not recruiting
Toledo, Ohio, United States, 43608
The Toledo Hospital Active, not recruiting
Toledo, Ohio, United States, 43606
Genesis-Good Samaritan Hospital Active, not recruiting
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Integris Baptist Medical Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Heart Hospital Active, not recruiting
Oklahoma City, Oklahoma, United States, 73120
Hillcrest Medical Center Recruiting
Tulsa, Oklahoma, United States, 74104
Principal Investigator: Raj Chandwaney, M.D.         
United States, Oregon
Providence St. Vincent Medical Center Active, not recruiting
Portland, Oregon, United States, 97225
PeaceHealth Sacred Heart Medical Center Active, not recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Abington Memorial Hospital Active, not recruiting
Abington, Pennsylvania, United States, 19001
Bryn Wawr Hospital Withdrawn
Bryn Mawr, Pennsylvania, United States, 19010
Holy Spirit Hospital Recruiting
Camp Hill, Pennsylvania, United States, 17011
Principal Investigator: Rajesh Dave, M.D.         
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822
Doylestown Hospital Active, not recruiting
Doylestown, Pennsylvania, United States, 18901
UPMC Hamot Active, not recruiting
Erie, Pennsylvania, United States, 16550
St. Mary Medical Center Active, not recruiting
Langhorne, Pennsylvania, United States, 19047
Forbes Hospital Recruiting
Monroeville, Pennsylvania, United States, 15146
Principal Investigator: Tony Farah, M.D.         
Pennsylvania Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Penn Presbyterian Medical Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: Tony Farah, M.D.         
UPMC Presbyterian Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC Shadyside Hospital Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15219
Pinnacle Health at Harrisburg Hospital Active, not recruiting
Wormleysburg, Pennsylvania, United States, 17043
St. Joseph Medical Center Active, not recruiting
Wyomissing, Pennsylvania, United States, 19610
York Hospital Active, not recruiting
York, Pennsylvania, United States, 17405
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Principal Investigator: Paul Gordon, M.D.         
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
AnMed Health Recruiting
Anderson, South Carolina, United States, 29621
Principal Investigator: Brent McLaurin, M.D.         
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
Sisters of Charity Providence Hospital Recruiting
Columbia, South Carolina, United States, 29204
Principal Investigator: Patrick Hall, M.D.         
St. Francis Health System Recruiting
Greenville, South Carolina, United States, 29607
Principal Investigator: John Cebe, M.D.         
Greenville Memorial Hospital of the Greenville Health System Active, not recruiting
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57104
Principal Investigator: Tomasz Stys, M.D.         
United States, Tennessee
Memorial Hospital Active, not recruiting
Chattanooga, Tennessee, United States, 37404
Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Principal Investigator: Christopher D. Metzger, M.D.         
Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Principal Investigator: Malcolm Foster, M.D.         
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Northwest Texas Healthcare System Active, not recruiting
Amarillo, Texas, United States, 79106
Seton Medical Center Austin Active, not recruiting
Austin, Texas, United States, 78705
Baylor Heart and Vascular Hospital Active, not recruiting
Dallas, Texas, United States, 75204
Texas Health Harris Methodist Withdrawn
Fort Worth, Texas, United States, 76104
Memorial Hermann - Hermann Hospital Withdrawn
Houston, Texas, United States, 77030
The Methodist Hospital Research Institute Active, not recruiting
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital Active, not recruiting
Houston, Texas, United States, 77030
The Heart Hospital Baylor Plano Active, not recruiting
Plano, Texas, United States, 75093
Methodist Texsan Hospital Active, not recruiting
San Antonio, Texas, United States, 78201
Scott and White Memorial Hospital Withdrawn
Temple, Texas, United States, 76508
East Texas Medical Center Recruiting
Tyler, Texas, United States, 75701
Principal Investigator: Robert Carney, M.D.         
Trinity Mother Frances Hospital Regional Healthcare Center Active, not recruiting
Tyler, Texas, United States, 75701
United States, Utah
InterMountain Medical Center Active, not recruiting
Murray, Utah, United States, 84107
United States, Vermont
Fletcher Allen Health Care Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Fairfax Hospital Active, not recruiting
Falls Church, Virginia, United States, 22042
Mary Washington Hospital Active, not recruiting
Fredericksburg, Virginia, United States, 22401
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Paul Mahoney, M.D.         
Carilion Roanoke Memorial Hospital Recruiting
Roanoke, Virginia, United States, 24014
Principal Investigator: Timothy Ball, M.D.         
Winchester Medical Center Active, not recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Overlake Hospital Medical Center Withdrawn
Bellevue, Washington, United States, 98004
St. Joseph's Hospital Active, not recruiting
Bellingham, Washington, United States, 98225
Providence Regional Medical Center Everett Active, not recruiting
Everett, Washington, United States, 98201
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98122
United States, West Virginia
St. Mary's Medical Center Active, not recruiting
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Suhail Allaqaband, M.D.         
Australia, New South Wales
Liverpool Hospital Withdrawn
Liverpool BC, New South Wales, Australia, 1871
Australia, Queensland
The Prince Charles Hospital Withdrawn
Chermside, Queensland, Australia, 4031
Royal Brisbane and Women's Hospital Active, not recruiting
Herston, Queensland, Australia, 4029
Australia, Victoria
St. Vincent's Hospital Melbourne Active, not recruiting
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Royal Perth Hospital Withdrawn
Perth, Western Australia, Australia, 6000
Canada, Quebec
CHUM-Hotel Dieu Withdrawn
Montreal, Quebec, Canada
Canada
Montreal Heart Institute Withdrawn
Montreal, Canada
St. Michael's Hospital Withdrawn
Toronto, Canada
Puerto Rico
Cardiovascular Center of Puerto Rico and the Caribbean Withdrawn
San Juan, Puerto Rico, 00936
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:
Absorb™ BVS
Angioplasty
Bioabsorbable
BVS
Bioresorbable
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:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Pathological Conditions, Anatomical
Heart Diseases
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 28, 2014