BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease
Phase 4
Withdrawn
- Conditions
- Angina Pectoris, Variant
- Interventions
- Device: BVS+OMT
- 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
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- WITHDRAWN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
- Arm && Interventions
Group Intervention Description BVS and OMT BVS+OMT Optimal medical treatment + BVS implantation
- Primary Outcome Measures
Name Time Method Composite of all cause death, myocardial infarction, and angina-related hospitalization 2year
- Secondary Outcome Measures
Name Time Method Variant angina 2year by Ergonovine test
Stroke 2year Cardiac death 2year Angina-related hospitalization 2year All cause death 2year Repeat revascularization 2year Scaffold thrombosis 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