BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease (BIVA-pilot)

Seung-Jung Park

Status and phase: Withdrawn; Phase 4

Conditions: Angina Pectoris, Variant

Treatments: Device: BVS+OMT

Study type: Interventional

Funder types: Other

Identifiers

NCT02932553

AMCCV2016-22

Details and patient eligibility

About

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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

BVS and OMT

Experimental group

Description:

Optimal medical treatment + BVS implantation

Treatment:

Device: BVS+OMT