Study of implantation of Abbott Vasculars Bioresorbable Vascular Scaffold in the treatment of coronary artery disease

Phase 3

• Conditions: Health Condition 1: null- Myocardial IschemiaCoronary Artery StenosisCoronary DiseaseCoronary Artery DiseaseCoronary RestenosisCardiovascular Disease

• Registration Number: CTRI/2010/091/000460
• Lead Sponsor: Abbott Cardiovascular Systems Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1000

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 &#8805; 50% and < 100% with a TIMI flow of &#8805; 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 &#8805; 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 greater than 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.

•Lesion(s) involving a bifurcation with side branch vessel greaterthan or equal to 2 mm in diameter and/or ostial lesion greater than 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure)Timepoint: Acute