Observational Study for Left Main Disease Treatment
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
-
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.
- 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 Death 10-year 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
Trial Locations
- Locations (40)
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Shin Kong Hospital
🇨🇳Taipei, Taiwan
Siriraj Hospital
🇹ðŸ‡Bangkok, Thailand
Hallym University medical center
🇰🇷Anyang, Korea, Republic of
Zhongshan Hospital
🇨🇳Shanghai, China
Soonchunhyang University Hospital, Buchen
🇰🇷Bucheon, Korea, Republic of
The Catholic University of Korea, Bucheon ST.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Soonchunhyang University Hospital, Cheonan
🇰🇷Cheonan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Gangneung Asan Medical Center
🇰🇷Gangneung, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
The Catholic University of Korea, Daejeon ST.Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Pusan Natioanal University Hospital
🇰🇷Pusan, Korea, Republic of
Bundang CHA Hospital
🇰🇷Seongnam, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju, Korea, Republic of
Kwangju Christian hospital
🇰🇷Kwangju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, ST. Paul's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Sarawak General Hospital
🇲🇾Kuching, Malaysia
The Catholic University of Korea, ST. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of
St.Mary's Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Dongguk University Medical Center
🇰🇷Seoul, Korea, Republic of
Kangbuk samsung hospital
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Veterans Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of