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ABSORB EXTEND Clinical Investigation

This study is currently recruiting participants.
Verified February 2013 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01023789
First received: November 30, 2009
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Disease
 Device: ABSORB BVS

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • (This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac Death (CD) [ Time Frame: 30, 180 days, and 1, 2, and 3 years. ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Myocardial Infarction (MI) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Target Vessel Myocardial Infarction (TV-MI) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia Driven MACE (ID MACE) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia driven Target Vessel Failure (ID TVF) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia Driven Target Lesion Revascularization (ID TLR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia Driven Target Vessel Revascularization (ID TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Scaffold thrombosis [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • OCT: Descriptive analysis of strut, lesion and vessel morphology post-procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • OCT: Scaffold area post-procedure (if analyzable) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • OCT: Lumen area [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • OCT: Minimum luminal area (MLA) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • OCT: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition [ Time Frame: 2 years (if analyzable) ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site Late Loss (LL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated segment LL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site and treated segment Minimum Luminal Diameter (MLD) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site and treated segment % Diameter Stenosis (DS) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site and treated segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Aneurysm, thrombus, persisting dissection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Vessel area [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Scaffold area (if analyzable) [ Time Frame: post-procedure and 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Minimum luminal area (MLA) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Treated site %Volume Obstruction (VO) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • MSCT subgroup: Descriptive analysis of vascular and scaffold morphology [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition [ Time Frame: 2 years (if analyzable) ] [ Designated as safety issue: No ]
  • Ischemia driven Non-Target Vessel Revascularization (ID non- TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Lumen area [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • Ischemia driven Non-Target Vessel Revascularization (ID non-TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months


Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABSORB BVS
ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
 Device: ABSORB BVS
ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation

  Eligibility

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

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 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, LCX with obtuse marginal and/or ramus intermedius branches and 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023789

Contacts
Contact: Candace Elek 408-845-3133 Candace.Elek@av.abbott.com

  Show 56 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Alexandre Abizaid, MD Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Study Chair: Patrick Serruys, MD Thoraxcenter-Erasmus University
  More Information

No publications provided by Abbott Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01023789     History of Changes
Other Study ID Numbers: 09-386, ACTRN12610000131055, REFCTRI000460, 03-05-2010
Study First Received: November 30, 2009
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Abbott Vascular:
Drug eluting stent
Stents
Angioplasty
 Bioabsorbable
Bioresorbable
Scaffold

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Coronary Stenosis
 Coronary Restenosis
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013