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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01341327
Other study ID # CVRF2010-08
Secondary ID
Status Recruiting
Phase N/A
First received April 22, 2011
Last updated July 19, 2017
Start date July 2007
Est. completion date July 2030

Study information

Verified date July 2017
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
Health authority
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 July 2030
Est. primary completion date July 2020
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

Study Design


Locations

Country Name City State
China Zhongshan Hospital Shanghai
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 Soonchunhyang University Hospital, Cheonan Cheonan
Korea, Republic of St.Mary's Catholic Medical Center Cheongju
Korea, Republic of The Catholic University of Korea, Daejeon ST.Mary's Hospital Daejeon
Korea, Republic of St.Mary's Catholic Medical Center Inchon
Korea, Republic of Pusan Natioanal University Hospital Pusan
Korea, Republic of Bundang CHA Hospital Seongnam
Korea, Republic of Cardio Vascular Research Foundation 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, Kangnam ST.Mary's Hospital Seoul
Korea, Republic of Yonsei University Medical Center Seoul
Korea, Republic of Ajou University 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, 

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