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

NCT ID: NCT02932553

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2017-04-19

Brief Summary

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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

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Conditions

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Angina Pectoris, Variant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BVS and OMT

Optimal medical treatment + BVS implantation

Group Type EXPERIMENTAL

BVS+OMT

Intervention Type DEVICE

bioresorbable vascular scaffold implantation plus optimal medical treatment

Interventions

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BVS+OMT

bioresorbable vascular scaffold implantation plus optimal medical treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

professor, Division of Cardiology, Department of Internal Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMCCV2016-22

Identifier Type: -

Identifier Source: org_study_id

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