NCT01341327

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
91mo left

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
5 countries

42 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jul 2007Dec 2033

Study Start

First participant enrolled

July 1, 2007

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
21.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

25.4 years

First QC Date

April 22, 2011

Last Update Submit

March 18, 2026

Conditions

Coronary Artery Disease

Keywords

Left Main

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Death

    10-year

  • Cardiac death

    10-year

  • Myocardial infarction

    10-year

  • Cerebrovascular event

    10-year

  • Target vessel revascularization

    10-year

  • +4 more secondary outcomes

Study Arms (1)

Left Main disease

Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.

You may qualify if:

  • 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.

You may not qualify if:

  • Protected left main stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Zhongshan Hospital

Shanghai, China

RECRUITING

Sarawak General Hospital

Kuching, Malaysia

RECRUITING

Hallym University medical center

Anyang, South Korea

RECRUITING

Soonchunhyang University Hospital, Buchen

Bucheon-si, South Korea

TERMINATED

The Catholic University of Korea, Bucheon ST.Mary's Hospital

Bucheon-si, South Korea

TERMINATED

Inje University Busan Paik Hospital

Busan, South Korea

RECRUITING

Soonchunhyang University Hospital, Cheonan

Cheonan, South Korea

RECRUITING

St.Mary's Catholic Medical Center

Cheongju-si, South Korea

TERMINATED

Daegu Catholic University Medical Center

Daegu, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, South Korea

TERMINATED

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

The Catholic University of Korea, Daejeon ST.Mary's Hospital

Daejeon, South Korea

TERMINATED

Gangneung Asan Medical Center

Gangneung, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

TERMINATED

St.Mary's Catholic Medical Center

Inchon, South Korea

TERMINATED

Chonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Presbyterian Medical Center

Jeonju, South Korea

RECRUITING

Kwangju Christian hospital

Kwangju, South Korea

RECRUITING

Pusan Natioanal University Hospital

Pusan, South Korea

RECRUITING

Bundang CHA Hospital

Seongnam, South Korea

TERMINATED

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Dongguk University Medical Center

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Kangbuk samsung hospital

Seoul, South Korea

RECRUITING

Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Korea University Anam hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Seoul National University Boramae Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul Veterans Hospital

Seoul, South Korea

TERMINATED

St.Mary's Catholic Medical Center

Seoul, South Korea

TERMINATED

The Catholic University of Korea, ST. Paul's Hospital

Seoul, South Korea

TERMINATED

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, South Korea

TERMINATED

Yonsei University Medical Center

Seoul, South Korea

TERMINATED

Ajou University Hospital

Suwon, South Korea

TERMINATED

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

Wonju Christian Hospital

Wŏnju, South Korea

RECRUITING

Shin Kong Hospital

Taipei, Taiwan

RECRUITING

Siriraj Hospital

Bangkok, Thailand

RECRUITING

Related Publications (5)

  • Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.

    PMID: 38199751DERIVED

  • Cho S, Kang DY, Kim JS, Park DW, Kim IS, Kang TS, Ahn JM, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK, Park SJ. Dual antiplatelet therapy after percutaneous coronary intervention for left main coronary artery disease. Rev Esp Cardiol (Engl Ed). 2023 Apr;76(4):245-252. doi: 10.1016/j.rec.2022.07.007. Epub 2022 Jul 27. English, Spanish.

    PMID: 35907438DERIVED

  • Park S, Ahn JM, Park H, Kang DY, Lee PH, Kim TO, Lee J, Kim JH, Yang Y, Jeong YJ, Hyun J, Kim AR, Kim T, Oh HJ, Lee YJ, Lee JH, Jang M, Park DW, Park SJ; IRIS-MAIN Registry Investigators. Comparison of Long-Term Outcomes Following Coronary Revascularization in Men-vs-Women with Unprotected Left Main Disease. Am J Cardiol. 2021 Aug 15;153:9-19. doi: 10.1016/j.amjcard.2021.05.016. Epub 2021 Jul 4.

    PMID: 34233836DERIVED

  • Park S, Ahn JM, Kim TO, Park H, Kang DY, Lee PH, Jeong YJ, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Park SJ, Park DW; IRIS-MAIN Registry Investigators. Revascularization in Patients With Left Main Coronary Artery Disease and Left Ventricular Dysfunction. J Am Coll Cardiol. 2020 Sep 22;76(12):1395-1406. doi: 10.1016/j.jacc.2020.07.047.

    PMID: 32943156DERIVED

  • Kang SH, Ahn JM, Lee CH, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Differential Event Rates and Independent Predictors of Long-Term Major Cardiovascular Events and Death in 5795 Patients With Unprotected Left Main Coronary Artery Disease Treated With Stents, Bypass Surgery, or Medication: Insights From a Large International Multicenter Registry. Circ Cardiovasc Interv. 2017 Jul;10(7):e004988. doi: 10.1161/CIRCINTERVENTIONS.116.004988.

    PMID: 28701487DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Seung-Jung Park, MD, PhD

    CVRF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Jung Park, MD, PhD

CONTACT

82-2-3010-3152sjpark@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

First Submitted

April 22, 2011

First Posted

April 25, 2011

Study Start

July 1, 2007

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2033

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial

Locations

CN(1)TW(1)MY(1)KR(38)TH(1)