ABSORB EXTEND Clinical Investigation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01023789
First received: November 30, 2009
Last updated: August 6, 2014
Last verified: August 2014

November 30, 2009
August 6, 2014
January 2010
October 2016   (final data collection date for primary outcome measure)
(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 ]
Not Provided
Complete list of historical versions of study NCT01023789 on ClinicalTrials.gov Archive Site
  • 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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
807
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 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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   India,   Italy,   Netherlands,   Taiwan,   Germany,   New Zealand,   Spain,   France,   Australia,   United Kingdom,   Switzerland,   Canada,   Malaysia,   Argentina,   Brazil,   Japan,   Sweden,   Singapore,   Belgium,   China,   Israel,   South Africa,   Poland,   Denmark
 
NCT01023789
09-386, ACTRN12610000131055, REFCTRI000460, 03-05-2010
Yes
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
August 2014

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