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

December 27, 2023 updated by: Seung-Jung Park

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BVS and OMT
Optimal medical treatment + BVS implantation
Device: BVS+OMT
bioresorbable vascular scaffold implantation plus optimal medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of all cause death, myocardial infarction, and angina-related hospitalization
Time Frame: 2year
2year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variant angina
Time Frame: 2year
by Ergonovine test
2year
All cause death
Time Frame: 2year
2year
Cardiac death
Time Frame: 2year
2year
Repeat revascularization
Time Frame: 2year
2year
Scaffold thrombosis
Time Frame: 2year
2year
Myocardial infarction
Time Frame: 2year
2year
Stroke
Time Frame: 2year
2year
Angina-related hospitalization
Time Frame: 2year
2year
Composite event of death or myocardial infarction
Time Frame: 2year
2year
Composite event of cardiac death or myocardial infarction
Time Frame: 2year
2year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Actual)

April 19, 2017

Study Completion (Actual)

April 19, 2017

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimated)

October 13, 2016

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2016-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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