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Arterial Occlusive DiseasesIRIS BVS AMINCT02699671

IRIS-BVS AMI Registry

An observational study of Arterial Occlusive Diseases and Cardiovascular Diseases, run by Duk-Woo Park, MD at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug eluting stents) DES. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Bioresorbable Vascular Scaffold
Type of treatment
Medical device
How many people
69 participants
Where
1 siteSouth Korea
Study dates
Jun 2016to Dec 2017
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: Acute myocardial infarction patients with Bioresorbable Vascular Scaffold

Who may be able to join

  • Age 19 and more
  • Acute myocardial infarction
  • 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

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Acute Myocardial Infarction; A Multicenter, Prospective Observational Study

The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug eluting stents) DES.

Being tested
Bioresorbable Vascular Scaffold
Keywords
Bioresorbable Vascular Scaffold, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease, drug eluting stent, acute myocardial infarction
Medical subject headings
Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioresorbable Vascular ScaffoldDevice

Study groups in NCT02699671
Study groupRoleWhat they receive
acute myocardial infarctionNot described
Receives: Device: Bioresorbable Vascular Scaffold

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite event

    The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

    Measured: 1year

Secondary outcomes (10)

  1. All death

    Measured: 5years

  2. Cardiac death

    Measured: 5years

  3. Myocardial infarction

    Measured: 5years

  4. Composite event of death or myocardial infarction

    Measured: 5years

  5. Composite event of cardiac death or myocardial infarction

    Measured: 5years

  6. 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: 5years

  7. 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: 5years

  8. 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: 5years

  9. Stroke

    Measured: 5years

  10. 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: 3days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: current BVS safety issue

Resources

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
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699671
Sponsor's protocol ID
AMCCV2016-01
Acronym
IRIS BVS AMI
Status last verified
Sep 2021
First submitted
1 Mar 2016
Last updated
13 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 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 4 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 13 Sep 2021. 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.

Are results available for this study?

The study was stopped early (reason given: current BVS safety issue). 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: 1year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02699671.

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 13 Sep 2021.

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