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IRIS-BVS AMI Registry (IRIS BVS AMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699671
Recruitment Status : Terminated (current BVS safety issue)
First Posted : March 4, 2016
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Duk-Woo Park, MD, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment
Arterial Occlusive Diseases Cardiovascular Diseases Coronary Artery Disease Device: Bioresorbable Vascular Scaffold

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Acute Myocardial Infarction; A Multicenter, Prospective Observational Study
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
acute myocardial infarction Device: Bioresorbable Vascular Scaffold



Primary Outcome Measures :
  1. Composite event [ Time Frame: 1year ]
    The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)


Secondary Outcome Measures :
  1. all death [ Time Frame: 5years ]
  2. cardiac death [ Time Frame: 5years ]
  3. myocardial infarction [ Time Frame: 5years ]
  4. Composite event of death or myocardial infarction [ Time Frame: 5years ]
  5. Composite event of cardiac death or myocardial infarction [ Time Frame: 5years ]
  6. Target Vessel revascularization [ Time Frame: 5years ]
    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 %

  7. Target Lesion revascularization [ Time Frame: 5years ]
    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.

  8. Stent thrombosis [ Time Frame: 5years ]
    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;

  9. Procedural success [ Time Frame: 3days ]
    Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute myocardial infarction patients with Bioresorbable Vascular Scaffold
Criteria

Inclusion Criteria:

  • Age 19 and more
  • Acute myocardial infarction
  • Intervention with Bioresorbable Vascular Scaffold
  • Agreed with written informed consent form

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699671


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea
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Responsible Party: Duk-Woo Park, MD, Principal investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02699671    
Other Study ID Numbers: AMCCV2016-01
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duk-Woo Park, MD, Asan Medical Center:
Bioresorbable Vascular Scaffold
Routine Clinical Practice
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease
drug eluting stent
acute myocardial infarction
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Heart Diseases
Arteriosclerosis
Vascular Diseases