- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932553
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
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
-
-
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Seoul, Korea, Republic of
- Asan Medical Center
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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
17 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
|
bioresorbable vascular scaffold implantation plus optimal medical treatment
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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
|
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Myocardial infarction
Time Frame: 2year
|
2year
|
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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
Collaborators
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.
Clinical Trials on Angina Pectoris, Variant
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Korea Otsuka Pharmaceutical Co., Ltd.CompletedVariant AnginaKorea, Republic of
-
Seoul National University HospitalUnknown
-
Samsung Medical CenterUnknownVariant AnginaKorea, Republic of
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentNot yet recruitingAngina Pectoris; Angiospastic
-
University Hospital, AntwerpRecruitingAngina Pectoris, Variant | Angina Pectoris; Spasm-Induced | Angina Pectoris With Normal Coronary ArteriogramBelgium
-
NHS National Waiting Times Centre BoardBritish Heart Foundation; University of Glasgow; NHS Greater Clyde and Glasgow; Chief Scientist Office of the Scottish GovernmentActive, not recruitingAngina, Stable | Angina Pectoris, Variant | Microvascular AnginaUnited Kingdom
-
Luzerner KantonsspitalUnknownAngina Pectoris | Angina Pectoris, Variant | Microvascular AnginaSwitzerland
-
Korea Otsuka Pharmaceutical Co., Ltd.CompletedVasospastic AnginaKorea, Republic of
-
Dong-A UniversityUnknown
-
Catharina Ziekenhuis EindhovenRecruitingMicrovascular Angina | Vasospastic AnginaNetherlands
Clinical Trials on BVS+OMT
-
Lake Erie College of Osteopathic MedicineCompleted
-
University of North Texas Health Science CenterOsteopathic Heritage Foundations; American Osteopathic AssociationTerminatedType 2 Diabetes Mellitus | Chronic Low Back PainUnited States
-
Dr. Sabrina OverhagenActive, not recruitingPeripheral Arterial Disease | Critical Limb IschemiaAustria, Germany
-
Icahn School of Medicine at Mount SinaiCompleted
-
MetiMedi PharmaceuticalsUnknown
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingCoronary Artery Disease | Myocardial IschaemiaChina
-
Abbott Medical DevicesCompletedAtherosclerosis | Peripheral Vascular Disease | ClaudicationAustria, France, Germany, Belgium
-
Abbott Medical DevicesWithdrawn
-
Abbott Medical DevicesCompletedMyocardial Ischemia | Coronary Artery Disease | Coronary Disease | Cardiovascular Disease | Coronary Restenosis | Coronary Artery StenosisNetherlands, Taiwan, China, New Zealand, Singapore, France, United Kingdom, Austria, Israel, Italy, Malaysia, India, Poland, Sweden, Spain, South Africa, Canada, Australia, Japan, Argentina, Brazil, Switzerland, Belgium, Denmark, Germany
-
J.J. WykrzykowskaAbbott Medical DevicesUnknownMyocardial Infarction | Infarction | Ischemia | Myocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Coronary Disease | Arteriosclerosis | Coronary Bifurcation Lesions | Arterial Occlusive LesionsNetherlands