BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease

Phase 4

Withdrawn

• Conditions: Angina Pectoris, Variant

• Registration Number: NCT02932553
• Lead Sponsor: Seung-Jung Park

Brief Summary

The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Study Start: 2017-04-19
• Primary Completion: 2017-04-19
• Study Completion: 2017-04-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 19 and more
• Vasospastic angina diagnosed by provocation test including ergonovine provocation coronary angiography or ergonovine echocardiogram
• No-ischemia producing moderate coronary artery disease(stenosis>50%, FFR>0.8)

Exclusion Criteria

• Ischemic coronary lesion
• Organic heart disease associated with myocardial ischemia or sudden cardiac death
• History of percutaneous coronary intervention
• Cerebrovascular diseases or peripheral disease
• NYHA III and IV
• Cardiac pacemaker or implantable defibrillator
• Pregnancy or breast feeding
• Life expectancy less than 2 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite of all cause death, myocardial infarction, and angina-related hospitalization	2year

Secondary Outcome Measures

Name	Time	Method
Cardiac death	2year
Angina-related hospitalization	2year
Variant angina	2year	by Ergonovine test
Stroke	2year
Scaffold thrombosis	2year
All cause death	2year
Repeat revascularization	2year
Myocardial infarction	2year
Composite event of death or myocardial infarction	2year
Composite event of cardiac death or myocardial infarction	2year

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of