Angina Pectoris, VariantPhase 4BIVA-pilotNCT02932553
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease
A Phase 4 study testing BVS+OMT in people with Angina Pectoris, Variant, run by Seung-Jung Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Angina Pectoris, Variant
- What is being tested?
- BVS+OMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Apr 2017to 19 Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Angina Pectoris, Variant
- Being tested
- BVS+OMT
- Keywords
- bioresorbable vascular scaffold, variant angina, moderate coronary artery disease, vasospastic angina
- Medical subject headings
- Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVS+OMTDevice
bioresorbable vascular scaffold implantation plus optimal medical treatment
| Study group | Role | What they receive |
|---|---|---|
| BVS and OMT | Experimental | Optimal medical treatment + BVS implantation Receives: Device: BVS+OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all cause death, myocardial infarction, and angina-related hospitalization
Measured: 2year
Secondary outcomes (10)
Variant angina
by Ergonovine test
Measured: 2year
All cause death
Measured: 2year
Cardiac death
Measured: 2year
Repeat revascularization
Measured: 2year
Scaffold thrombosis
Measured: 2year
Myocardial infarction
Measured: 2year
Stroke
Measured: 2year
Angina-related hospitalization
Measured: 2year
Composite event of death or myocardial infarction
Measured: 2year
Composite event of cardiac death or myocardial infarction
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start19 Apr 2017
- Primary completion19 Apr 2017
- Study completion19 Apr 2017
Why it stopped: BVS was withdrawn from the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina Pectoris, VariantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932553
- Sponsor's protocol ID
- AMCCV2016-22
- Acronym
- BIVA-pilot
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2016
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease: Pilot Study
- ClinicalTrials.gov ID
- NCT02932553
- Acronym / sponsor ID
- BIVA-pilot / AMCCV2016-22
- Conditions
- Angina Pectoris, Variant
- Keywords
- bioresorbable vascular scaffold, variant angina, moderate coronary artery disease, vasospastic angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: BVS was withdrawn from the market
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BVS and OMT | Experimental | Device: BVS+OMTOptimal medical treatment + BVS implantation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVS+OMTbioresorbable vascular scaffold implantation plus optimal medical treatment | Device | BVS and OMT |
Primary outcome
Composite of all cause death, myocardial infarction, and angina-related hospitalization
Time frame: 2year
10 secondary outcomes
Variant angina
Time frame: 2year
All cause death
Time frame: 2year
Cardiac death
Time frame: 2year
Repeat revascularization
Time frame: 2year
Scaffold thrombosis
Time frame: 2year
Myocardial infarction
Time frame: 2year
Stroke
Time frame: 2year
Angina-related hospitalization
Time frame: 2year
Composite event of death or myocardial infarction
Time frame: 2year
Composite event of cardiac death or myocardial infarction
Time frame: 2year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Angina Pectoris, Variant
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Gangwon PCI Prospective Registry
Coronary Artery Disease, Ischemic Heart Disease (IHD)
RecruitingPhase 4
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Angina Pectoris, Variant, Sudden Cardiac Death
Recruiting
iCorMicA - Stratified Medicine in Angina
Microvascular Angina, Angina, Stable
Active, not recruiting
Cardioneuroablation for Variant Angina
Variant Angina
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BVS+OMT in people with Angina Pectoris, Variant, run by Seung-Jung Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all cause death, myocardial infarction, and angina-related hospitalization (time frame: 2year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.