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Observational Study for Left Main Disease Treatment (IRIS-MAIN)

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ClinicalTrials.gov Identifier: NCT01341327
Recruitment Status : Recruiting
First Posted : April 25, 2011
Last Update Posted : April 4, 2023
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Study Description
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Brief Summary:
The purpose of this study is to observe clinical courses for long-term in patients with unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis in the "real world" daily practice.

Condition or disease
Coronary Artery Disease

Detailed Description:
This study is a multicenter, large clinical registry to evaluate comparative outcomes of medical therapy, PCI with DES, or CABG for patients with unprotected LMCA stenosis in the Asia-Pacific, as recorded in the MAIN-IRIS Registry. Data will be prospectively collected on approximately 5000 subjects who diagnosed LM disease (>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region. Brief study design is as depicted in the following figure
Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT
Actual Study Start Date : July 2007
Estimated Primary Completion Date : December 2032
Estimated Study Completion Date : December 2033
Groups and Cohorts
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Group/Cohort
Left Main disease
Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.


Outcome Measures
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Primary Outcome Measures :
  1. Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event [ Time Frame: 2-year ]
    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.


Secondary Outcome Measures :
  1. Death [ Time Frame: 10-year ]
  2. Cardiac death [ Time Frame: 10-year ]
  3. Myocardial infarction [ Time Frame: 10-year ]
  4. Cerebrovascular event [ Time Frame: 10-year ]
  5. Target vessel revascularization [ Time Frame: 10-year ]
  6. Target lesion revascularization [ Time Frame: 10-year ]
  7. Stent thrombosis [ Time Frame: 10-year ]
    According to Academic Research Consortium (ARC) criteria

  8. Binary restenosis and late luminal loss in both in-stent and in-segment [ Time Frame: 9-month ]
    Angiographic follow-up in the PCI group (as form of PCI substudy)

  9. Rehospitalization [ Time Frame: 10-year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.
Criteria

Inclusion Criteria:

  • Significant unprotected left main stenosis (>50% by visual estimation)

    • The LMCA is considered unprotected if there are no patent coronary artery bypass grafts to the left anterior descending artery or the left circumflex artery.
  • No limitation of clinical or lesion characteristics
  • Age >18 years
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

  • Protected left main stenosis
Contacts and Locations
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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): NCT01341327


Contacts
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Contact: Seung-Jung Park, MD, PhD 82-2-3010-3152 sjpark@amc.seoul.kr

Locations
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Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Seung-Jung Park, MD, PhD CVRF
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01341327    
Other Study ID Numbers: CVRF2010-08
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial
Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
Left Main
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases