NCT02932553

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2017

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

Same day

First QC Date

October 12, 2016

Last Update Submit

December 27, 2023

Conditions

Angina Pectoris, Variant

Keywords

bioresorbable vascular scaffoldvariant anginamoderate coronary artery diseasevasospastic angina

Outcome Measures

Primary Outcomes (1)

  • Composite of all cause death, myocardial infarction, and angina-related hospitalization

    2year

Secondary Outcomes (10)

  • Variant angina

    2year

  • All cause death

    2year

  • Cardiac death

    2year

  • Repeat revascularization

    2year

  • Scaffold thrombosis

    2year

  • +5 more secondary outcomes

Study Arms (1)

BVS and OMT

EXPERIMENTAL

Optimal medical treatment + BVS implantation

Device: BVS+OMT

Interventions

BVS+OMTDEVICE

bioresorbable vascular scaffold implantation plus optimal medical treatment

BVS and OMT

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Angina Pectoris, Variant

Condition Hierarchy (Ancestors)

Angina, UnstableAngina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor, Division of Cardiology, Department of Internal Medicine

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

April 19, 2017

Primary Completion

April 19, 2017

Study Completion

April 19, 2017

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

KR(1)