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

Angina Pectoris, Variant Clinical Trial

— BIVA-pilot  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02932553
• Other study ID #: AMCCV2016-22
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 19, 2017
• Est. completion date: April 19, 2017

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 19, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• BVS+OMT
bioresorbable vascular scaffold implantation plus optimal medical treatment

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all cause death, myocardial infarction, and angina-related hospitalization		2year
Secondary	Variant angina	by Ergonovine test	2year
Secondary	All cause death		2year
Secondary	Cardiac death		2year
Secondary	Repeat revascularization		2year
Secondary	Scaffold thrombosis		2year
Secondary	Myocardial infarction		2year
Secondary	Stroke		2year
Secondary	Angina-related hospitalization		2year
Secondary	Composite event of death or myocardial infarction		2year
Secondary	Composite event of cardiac death or myocardial infarction		2year