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Clinical Trials/NCT01023789
NCT01023789CompletedNot Applicable

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

Abbott Medical Devices56 sites in 21 countries812 target enrollmentStarted: January 1, 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
812
Locations
56
Primary Endpoint
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 ≥
  • •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).

Arms & Interventions

ABSORB BVS

Experimental

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease

Intervention: ABSORB BVS (Device)

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Mean Reference Area(18 months)
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)(0 to 3 years)
  • Minimum Vessel Area(18 months)
  • Maximum Lumen Area(18 months)
  • Maximum Plaque Area(18 months)
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)(0 to 3 years)
  • Mean Lumen Area(18 months)
  • Minimum Plaque Area(18 months)
  • Number of Participants With Cardiac Death(0 to 3 years)
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)(0 to 3 years)
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)(0 to 3 years)
  • Maximum Vessel Area(18 months)
  • Clinical Device Success(On day 0 (immediate post-index procedure))
  • Clinical Procedure Success(On day 0 (immediate post-index procedure))
  • Number of Participants With Scaffold Thrombosis (Early)(0 to 30 days)
  • Number of Participants With Scaffold Thrombosis (Late)(31 - 365 days)
  • Number of Participants With Scaffold Thrombosis (Very Late)(366 days to 2 years)
  • Area Stenosis (%)(18 months)
  • Minimum Lumen Area(18 months)
  • Mean Vessel Area(18 months)
  • Mean Plaque Area(18 months)
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol(0 to 3 years)
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)(0 to 3 years)
  • Number of Participants With Scaffold Thrombosis(0 to 3 years)
  • Calculated Minimum Lumen Diameter(18 months)
  • Calculated Diameter Stenosis(18 months)
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)(≤ 7 days post index procedure (In-hospital ))
  • Number of Participants With Cardiac Death(≤ 7 days post index procedure (In-hospital ))
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol(≤ 7 days post index procedure (In-hospital ))
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)(≤ 7 days post index procedure (In-hospital ))
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)(≤ 7 days post index procedure (In-hospital ))
  • Number of Participants With Cardiac Death(0 to 30 days)
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol(0 to 30 days)
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)(0 to 30 days)
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)(0 to 30 days)
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)(0 to 30 days)
  • Number of Participants With Cardiac Death(0 to 180 days)
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol(0 to 180 days)
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)(0 to 180 days)
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)(0 to 180 days)
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)(0 to 180 days)
  • Number of Participants With Cardiac Death(0 to 1 year)
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol(0 to 1 year)
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)(0 to 1 year)
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)(0 to 1 year)
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)(0 to 1 year)
  • Number of Participants With Cardiac Death(0 to 2 year)
  • Number of Participants With Myocardial Infarction (MI) - Per Protocol(0 to 2 year)
  • Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)(0 to 2 year)
  • Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)(0 to 2 year)
  • Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)(0 to 2 year)
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)(≤ 7 days post index procedure (In hospital))
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)(0 to 30 days)
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)(0 to 180 days)
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)(0 to 1 year)
  • Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)(0 to 2 years)
  • Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)(0 to 2 years)
  • Number of Participants With Scaffold Thrombosis(0 to 180 days)
  • Number of Participants With Scaffold Thrombosis(0 to 1 year)
  • Number of Participants With Scaffold Thrombosis(0 to 2 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (56)

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