Angina Pectoris, Variant
Conditions
Keywords
bioresorbable vascular scaffold, variant angina, moderate coronary artery disease, vasospastic angina
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.
Interventions
DEVICEBVS+OMT
bioresorbable vascular scaffold implantation plus optimal medical treatment
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all cause death, myocardial infarction, and angina-related hospitalization | 2year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | 2year | — |
| Cardiac death | 2year | — |
| Repeat revascularization | 2year | — |
| Scaffold thrombosis | 2year | — |
| Variant angina | 2year | by Ergonovine test |
| Stroke | 2year | — |
| Angina-related hospitalization | 2year | — |
| Composite event of death or myocardial infarction | 2year | — |
| Composite event of cardiac death or myocardial infarction | 2year | — |
| Myocardial infarction | 2year | — |
Countries
South Korea
Outcome results
None listed