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ABSORB EXTEND Clinical Investigation (ABSORB EXTEND)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01023789
First Posted: December 2, 2009
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Abbott Vascular
  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: Intervention Model: Single Group Assignment
Masking: None (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

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 ]

Secondary Outcome Measures:
  • Cardiac Death (CD) [ Time Frame: 30, 180 days, and 1, 2, and 3 years. ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • OCT: Scaffold area post-procedure (if analyzable) [ Time Frame: 2 years ]
  • OCT: Lumen area [ Time Frame: post-procedure and at 2 years ]
  • OCT: Minimum luminal area (MLA) [ Time Frame: post-procedure and at 2 years ]
  • OCT: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition [ Time Frame: 2 years (if analyzable) ]
  • Angiographic OCT subgroup: Treated site Late Loss (LL) [ Time Frame: 2 years ]
  • Angiographic OCT subgroup: Treated segment LL [ Time Frame: 2 years ]
  • Angiographic OCT subgroup: Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement) [ Time Frame: 2 years ]
  • Angiographic OCT subgroup: Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement) [ Time Frame: 2 years ]
  • Angiographic OCT subgroup: Treated site and treated segment Minimum Luminal Diameter (MLD) [ Time Frame: post-procedure and at 2 years ]
  • Angiographic OCT subgroup: Treated site and treated segment % Diameter Stenosis (DS) [ Time Frame: post-procedure and at 2 years ]
  • Angiographic OCT subgroup: Treated site and treated segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: 2 years ]
  • Angiographic OCT subgroup: Aneurysm, thrombus, persisting dissection [ Time Frame: 2 years ]
  • IVUS OCT subgroup: Vessel area [ Time Frame: post-procedure and at 2 years ]
  • IVUS OCT subgroup: Scaffold area (if analyzable) [ Time Frame: post-procedure and 2 years ]
  • IVUS OCT subgroup: Minimum luminal area (MLA) [ Time Frame: post-procedure and at 2 years ]
  • IVUS OCT subgroup: Treated site %Volume Obstruction (VO) [ Time Frame: 2 years ]
  • MSCT subgroup: Descriptive analysis of vascular and scaffold morphology [ Time Frame: 18 months ]
  • IVUS OCT subgroup: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition [ Time Frame: 2 years (if analyzable) ]
  • Ischemia driven Non-Target Vessel Revascularization (ID non- TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Lumen area [ Time Frame: post-procedure and at 2 years ]
  • Ischemia driven Non-Target Vessel Revascularization (ID non-TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months


Estimated Enrollment: 807
Study Start Date: January 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023789


  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

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 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
REFCTRI000460, 03-05-2010 ( Registry Identifier: Clinical Trials Registry - India )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Last Update Posted: October 12, 2017
Last Verified: January 2016

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