Observational Study for Left Main Disease Treatment

Coronary Artery Disease Clinical Trial

— IRIS-MAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01341327
• Other study ID #: CVRF2010-08
• Status: Recruiting
• Start date: July 2007
• Est. completion date: December 2033

Study information

• Verified date: April 2023
• Source: CardioVascular Research Foundation, Korea
• Contact: Seung-Jung Park, MD, PhD
• Phone: 82-2-3010-3152
• Email: sjpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2033
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai
Korea, Republic of	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	Cheongju
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	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST.Mary's Hospital	Daejeon
Korea, Republic of	Gangneung Asan Medical Center	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Ilsan
Korea, Republic of	St.Mary's Catholic Medical Center	Inchon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Kwangju Christian hospital	Kwangju
Korea, Republic of	Pusan Natioanal University Hospital	Pusan
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Dongguk University Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	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	St.Mary's Catholic Medical Center	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	Yonsei University Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Christian Hospital	Wonju
Malaysia	Sarawak General Hospital	Kuching
Taiwan	Shin Kong Hospital	Taipei
Thailand	Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Countries where clinical trial is conducted

China,  Korea, Republic of,  Malaysia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death		10-year
Secondary	Cardiac death		10-year
Secondary	Myocardial infarction		10-year
Secondary	Cerebrovascular event		10-year
Secondary	Target vessel revascularization		10-year
Secondary	Target lesion revascularization		10-year
Secondary	Stent thrombosis	According to Academic Research Consortium (ARC) criteria	10-year
Secondary	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
Secondary	Rehospitalization		10-year