BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease (BIVA-pilot)
Primary Purpose
Angina Pectoris, Variant
Status
Enrolling by invitation
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BVS+OMT
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris, Variant focused on measuring bioresorbable vascular scaffold, variant angina, moderate coronary artery disease, vasospastic angina
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BVS and OMT
Arm Description
Optimal medical treatment + BVS implantation
Outcomes
Primary Outcome Measures
Composite of all cause death, myocardial infarction, and angina-related hospitalization
Secondary Outcome Measures
Variant angina
by Ergonovine test
All cause death
Cardiac death
Repeat revascularization
Scaffold thrombosis
Myocardial infarction
Stroke
Angina-related hospitalization
Composite event of death or myocardial infarction
Composite event of cardiac death or myocardial infarction
Full Information
NCT ID
NCT02932553
First Posted
October 12, 2016
Last Updated
December 12, 2022
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02932553
Brief Title
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease
Acronym
BIVA-pilot
Official Title
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Variant
Keywords
bioresorbable vascular scaffold, variant angina, moderate coronary artery disease, vasospastic angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BVS and OMT
Arm Type
Experimental
Arm Description
Optimal medical treatment + BVS implantation
Intervention Type
Device
Intervention Name(s)
BVS+OMT
Intervention Description
bioresorbable vascular scaffold implantation plus optimal medical treatment
Primary Outcome Measure Information:
Title
Composite of all cause death, myocardial infarction, and angina-related hospitalization
Time Frame
2year
Secondary Outcome Measure Information:
Title
Variant angina
Description
by Ergonovine test
Time Frame
2year
Title
All cause death
Time Frame
2year
Title
Cardiac death
Time Frame
2year
Title
Repeat revascularization
Time Frame
2year
Title
Scaffold thrombosis
Time Frame
2year
Title
Myocardial infarction
Time Frame
2year
Title
Stroke
Time Frame
2year
Title
Angina-related hospitalization
Time Frame
2year
Title
Composite event of death or myocardial infarction
Time Frame
2year
Title
Composite event of cardiac death or myocardial infarction
Time Frame
2year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease
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