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ABSORB EXTEND Clinical Investigation (ABSORB EXTEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023789
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : December 18, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

November 30, 2009
December 2, 2009
May 18, 2017
December 18, 2017
February 14, 2018
January 2010
October 2016   (Final data collection date for primary outcome measure)
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: ≤ 7 days post index procedure (In hospital) ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
    • Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 30 days ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
    • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 180 days ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 1 year ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Not Provided
Complete list of historical versions of study NCT01023789 on ClinicalTrials.gov Archive Site
  • Clinical Device Success [ Time Frame: On day 0 (immediate post-index procedure) ]
    Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.
  • Clinical Procedure Success [ Time Frame: On day 0 (immediate post-index procedure) ]
    Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.
  • Number of Participants With Cardiac Death [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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.
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

    Revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

    Revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
  • Number of Participants With Cardiac Death [ Time Frame: 0 to 30 days ]
    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.
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 30 days ]
    Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 30 days ]

    Revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 30 days ]

    Revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 30 days ]
  • Number of Participants With Cardiac Death [ Time Frame: 0 to 180 days ]
    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.
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 180 days ]
    Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 180 days ]

    Revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 180 days ]

    Revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 180 days ]
  • Number of Participants With Cardiac Death [ Time Frame: 0 to 1 year ]
    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.
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 1 year ]
    Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 1 year ]

    Revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 1 year ]

    Revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 1 year ]
  • Number of Participants With Cardiac Death [ Time Frame: 0 to 2 year ]
    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.
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 2 year ]
    Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 2 year ]

    Revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 2 year ]

    Revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 2 year ]
  • Number of Participants With Cardiac Death [ Time Frame: 0 to 3 years ]
    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.
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol [ Time Frame: 0 to 3 years ]
    Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) [ Time Frame: 0 to 3 years ]

    Revascularization at the target lesion associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 0 to 3 years ]

    Revascularization in the target vessel associated with any of the following:

    • Positive functional ischemia study.
    • Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
    • Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) [ Time Frame: 0 to 3 years ]
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: ≤ 7 days post index procedure (In hospital) ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 30 days ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 180 days ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 1 year ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 2 years ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) [ Time Frame: 0 to 3 years ]

    The composite endpoint composed of

    • Cardiac death,
    • Myocardial infarction (Q wave and Non-Q wave),
    • Ischemia-driven target vessel revascularization by CABG or PCI.
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 2 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) [ Time Frame: 0 to 3 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
  • Number of Participants With Scaffold Thrombosis (Early) [ Time Frame: 0 to 30 days ]

    According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  • Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 180 days ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  • Number of Participants With Scaffold Thrombosis (Late) [ Time Frame: 31 - 365 days ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  • Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 1 year ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  • Number of Participants With Scaffold Thrombosis (Very Late) [ Time Frame: 366 days to 2 years ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  • Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 2 years ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  • Number of Participants With Scaffold Thrombosis [ Time Frame: 0 to 3 years ]

    According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing:

    Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

    *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).

    †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.

  • Area Stenosis (%) [ Time Frame: 18 months ]
  • Minimum Lumen Area [ Time Frame: 18 months ]
  • Mean Vessel Area [ Time Frame: 18 months ]
  • Minimum Vessel Area [ Time Frame: 18 months ]
  • Maximum Vessel Area [ Time Frame: 18 months ]
  • Mean Lumen Area [ Time Frame: 18 months ]
  • Maximum Lumen Area [ Time Frame: 18 months ]
  • Mean Plaque Area [ Time Frame: 18 months ]
  • Minimum Plaque Area [ Time Frame: 18 months ]
  • Maximum Plaque Area [ Time Frame: 18 months ]
  • Mean Reference Area [ Time Frame: 18 months ]
  • Calculated Minimum Lumen Diameter [ Time Frame: 18 months ]
    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
  • Calculated Diameter Stenosis [ Time Frame: 18 months ]
    The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Not Provided
Not Provided
Not Provided
 
ABSORB EXTEND Clinical Investigation
ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
  • Cardiovascular Disease
Device: ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation
Experimental: ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Intervention: Device: ABSORB BVS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
812
October 2016
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
  • Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
  • Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
  • If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
  • Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
  • Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.

Exclusion Criteria:

  • Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
  • Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
  • Total occlusion (TIMI flow 0), prior to wire passing.
  • Target vessel(s) contains visible thrombus.
  • Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
  • Subject has received brachytherapy in any epicardial vessel (including side branches).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Denmark,   France,   Germany,   India,   Israel,   Italy,   Japan,   Malaysia,   Netherlands,   New Zealand,   Poland,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
 
 
NCT01023789
09-386
ACTRN12610000131055 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
REFCTRI000460, 03-05-2010 ( Registry Identifier: Clinical Trials Registry - India )
Yes
Not Provided
Not Provided
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Alexandre Abizaid, MD Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Study Chair: Patrick Serruys, MD Thoraxcenter-Erasmus University
Abbott Vascular
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP