Arterial Occlusive DiseasesIRIS BVSNCT02622100
Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice
An observational study of Arterial Occlusive Diseases and Cardiovascular Diseases, run by Duk-Woo Park, MD at 14 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease
- What is being tested?
- Bioresorbable Vascular Scaffold
- Type of treatment
- Medical device
- How many people
- 629 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 26 Feb 2016to Dec 2023
- Phase
- Observational
- 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
Study population: patients with Bioresorbable Vascular Scaffold
Who may be able to join
- Age 19 and more
- Intervention with Bioresorbable Vascular Scaffold
- Agreed with written informed consent form
Who cannot join
- Bypass graft surgery (CABG) recommended
- Lesion with previous bypass graft surgery (CABG)
- Severe calcification and/or severe tortuosity
- Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
- Life expectancy of 1year and under
- Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
- Cardiac shock
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Hallym University Sacred Heart Hospital
Anyang
Gangwon National Univ. Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
ChonBuk National University Hospital
Jeonju
Bundang CHA Hospital
Seongnam
Asan Medical Center
Seoul, Songpa-gu, 138-736
Korea University Guro Hospital
Seoul
Ulsan University Hospital
Ulsan
Wonju Severance Christian Hosp
Wŏnju
About this study
Official title: Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice; A Multicenter, Prospective Observational Study
The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.
- Conditions
- Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease
- Being tested
- Bioresorbable Vascular Scaffold
- Keywords
- Bioresorbable Vascular Scaffold, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease, drug eluting stent
- Medical subject headings
- Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable Vascular ScaffoldDevice
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable Vascular Scaffold | Not described Receives: Device: Bioresorbable Vascular Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event
The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
Measured: 1 year
Secondary outcomes (10)
all death
Measured: 5 years
cardiac death
Measured: 5 years
myocardial infarction
Measured: 5 years
Composite event of death or myocardial infarction
Measured: 5 years
Composite event of cardiac death or myocardial infarction
Measured: 5 years
Target Vessel revascularization
Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve).
Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %
Measured: 5 years
Target Lesion revascularization
Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Measured: 5 years
Stent thrombosis
DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post;
Measured: 5 years
Stroke
Measured: 5 years
Procedural success
Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start26 Feb 2016
- Primary completion23 Mar 2019
- Study completionDec 2023
Why it stopped: Due to stop BVS supply discontinuation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duk-Woo Park, MD
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Duk-Woo Park, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622100
- Sponsor's protocol ID
- AMCCV2015-11
- Acronym
- IRIS BVS
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2015
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02622100
- Acronym / sponsor ID
- IRIS BVS / AMCCV2015-11
- Conditions
- Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease
- Keywords
- Bioresorbable Vascular Scaffold, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease, drug eluting stent
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to stop BVS supply discontinuation
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Duk-Woo Park, MDUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 4 Dec 2015 (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 evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable Vascular Scaffold | – | Device: Bioresorbable Vascular Scaffold |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Bioresorbable Vascular Scaffold
Key inclusion criteria (3 listed)
- Age 19 and more
- Intervention with Bioresorbable Vascular Scaffold
- Agreed with written informed consent form
Key exclusion criteria (7 listed)
- Bypass graft surgery (CABG) recommended
- Lesion with previous bypass graft surgery (CABG)
- Severe calcification and/or severe tortuosity
- Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
- Life expectancy of 1year and under
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 |
|---|---|---|
| Bioresorbable Vascular Scaffold | Device | Bioresorbable Vascular Scaffold |
Primary outcome
Composite event
Time frame: 1 year
The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
10 secondary outcomes
all death
Time frame: 5 years
cardiac death
Time frame: 5 years
myocardial infarction
Time frame: 5 years
Composite event of death or myocardial infarction
Time frame: 5 years
Composite event of cardiac death or myocardial infarction
Time frame: 5 years
Target Vessel revascularization
Time frame: 5 years
Target Lesion revascularization
Time frame: 5 years
Stent thrombosis
Time frame: 5 years
Stroke
Time frame: 5 years
Procedural success
Time frame: 3 days
Results and safety
The study was stopped early (reason given: Due to stop BVS supply discontinuation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Occlusive Diseases and Cardiovascular Diseases, run by Duk-Woo Park, MD at 14 sites 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 7 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: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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.
Are results available for this study?
The study was stopped early (reason given: Due to stop BVS supply discontinuation). Results are not available in the source record.
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 event (time frame: 1 year). 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 20 Dec 2023.