Overview

This trial is active, not recruiting.

Conditions myocardial ischemia, coronary artery stenosis, coronary disease, coronary artery disease, coronary restenosis, cardiovascular disease
Treatment absorb bvs
Sponsor Abbott Vascular
Start date January 2010
End date October 2016
Trial size 807 participants
Trial identifier NCT01023789, 09-386, ACTRN12610000131055, REFCTRI000460, 03-05-2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
absorb bvs
ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation

Primary Outcomes

Measure
(This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure)
time frame: Acute

Secondary Outcomes

Measure
Cardiac Death (CD)
time frame: 30, 180 days, and 1, 2, and 3 years.
Myocardial Infarction (MI)
time frame: 30, 180 days, and 1, 2, and 3 years
Target Vessel Myocardial Infarction (TV-MI)
time frame: 30, 180 days, and 1, 2, and 3 years
Ischemia Driven MACE (ID MACE)
time frame: 30, 180 days, and 1, 2, and 3 years
Ischemia driven Target Vessel Failure (ID TVF)
time frame: 30, 180 days, and 1, 2, and 3 years
Ischemia Driven Target Lesion Revascularization (ID TLR)
time frame: 30, 180 days and 1, 2, and 3 years
Ischemia Driven Target Vessel Revascularization (ID TVR)
time frame: 30, 180 days and 1, 2, and 3 years
Scaffold thrombosis
time frame: 30, 180 days, and 1, 2, and 3 years
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Principal investigator Alexandre Abizaid, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Abbott Vascular.