Observational Study for Left Main Disease Treatment

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT01341327
• Lead Sponsor: Seung-Jung Park

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.

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2011-04-22
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2032-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event	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

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

Trial Locations

Locations (40)

Zhongshan Hospital; 🇨🇳 Shanghai, China

Hallym University medical center; 🇰🇷 Anyang, Korea, Republic of

Soonchunhyang University Hospital, Buchen; 🇰🇷 Bucheon, Korea, Republic of

The Catholic University of Korea, Bucheon ST.Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Soonchunhyang University Hospital, Cheonan; 🇰🇷 Cheonan, Korea, Republic of

St.Mary's Catholic Medical Center; 🇰🇷 Seoul, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

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