Observational Study for Left Main Disease Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left Main disease<br>Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event | 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. | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 10-year | 
| Cardiac death |  | 10-year | 
| Myocardial infarction |  | 10-year | 
| Cerebrovascular event |  | 10-year | 
| Target vessel revascularization |  | 10-year | 
| Target lesion revascularization |  | 10-year | 
| Stent thrombosis | According to Academic Research Consortium (ARC) criteria | 10-year | 
| Binary restenosis and late luminal loss in both in-stent and in-segment | Angiographic follow-up in the PCI group (as form of PCI substudy) | 9-month | 
| Rehospitalization |  | 10-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Main