Observational Study for Left Main Disease Treatment (IRIS-MAIN)

March 18, 2026 updated by: Seung-Jung Park

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital
        • Contact:
          • Junbo Ge
  • Malaysia
      • Kuching, Malaysia
        • Recruiting
        • Sarawak General Hospital
        • Contact:
          • K.H. Shim
        • Principal Investigator:
          • K.H. Shim
  • South Korea
      • Anyang, South Korea
        • Recruiting
        • Hallym University Medical Center
        • Contact:
          • Woo-jung Park, MD
        • Principal Investigator:
          • woo-jung Park, MD
      • Bucheon-si, South Korea
        • Terminated
        • Soonchunhyang University Hospital, Buchen
      • Bucheon-si, South Korea
        • Terminated
        • The Catholic University of Korea, Bucheon St.Mary's Hospital
      • Busan, South Korea
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Tae-hyun Yang, MD
        • Principal Investigator:
          • Tae-hyun Yang, MD
      • Cheonan, South Korea
        • Recruiting
        • Soonchunhyang University Hospital, Cheonan
        • Contact:
          • Won Yong Shin
      • Cheongju-si, South Korea
        • Terminated
        • St.Mary's Catholic Medical Center
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
          • Seung-ho Hur, MD
        • Principal Investigator:
          • Seung-ho Hur, MD
      • Daegu, South Korea
        • Recruiting
        • Daegu Catholic University Medical Center
        • Contact:
          • Kee-sik Kim, MD
        • Principal Investigator:
          • Kee-sik Kim, MD
      • Daegu, South Korea
        • Terminated
        • Yeungnam University Medical Center
      • Daejeon, South Korea
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Jin-ok Jeong, MD
        • Principal Investigator:
          • Jin-ok Jeong, MD
      • Daejeon, South Korea
        • Terminated
        • The Catholic University of Korea, Daejeon St.Mary's Hospital
      • Gangneung, South Korea
        • Recruiting
        • Gangneung Asan Medical Center
        • Contact:
          • Sang-sig Cheong, MD
        • Principal Investigator:
          • Sang-sig Cheong, MD
      • Gwangju, South Korea
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
          • Myung-ho Jeong, MD
        • Principal Investigator:
          • Myung-ho Jeong, MD
      • Ilsan, South Korea
        • Terminated
        • National Health Insurance Service Ilsan Hospital
      • Inchon, South Korea
        • Terminated
        • St.Mary's Catholic Medical Center
      • Jeonju, South Korea
        • Recruiting
        • Presbyterian Medical Center
        • Contact:
          • Jay-young Rhew, MD
        • Principal Investigator:
          • Jay-young Rhew, MD
      • Jeonju, South Korea
        • Recruiting
        • Chonbuk National University Hospital
        • Contact:
          • Jei-keon Chae, MD
        • Principal Investigator:
          • Jei-keon Chae, MD
      • Kwangju, South Korea
        • Recruiting
        • Kwangju Christian hospital
        • Contact:
          • Seung-uk Lee, MD
        • Principal Investigator:
          • Seung-uk Lee, MD
      • Pusan, South Korea
        • Recruiting
        • Pusan Natioanal University Hospital
        • Contact:
          • June-Hong Kim, MD, PhD
        • Principal Investigator:
          • June-Hong Kim, MD, PhD
      • Seongnam, South Korea
        • Terminated
        • Bundang CHA Hospital
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hyo-Soo Kim, MD, PhD
        • Principal Investigator:
          • Hyo-Soo Kim, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • Seung-un Na, MD
        • Principal Investigator:
          • Seung-un Na, MD
      • Seoul, South Korea, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Seung-jung Park, MD
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Do-sun Lim, MD
        • Principal Investigator:
          • Do-sun Lim, MD
      • Seoul, South Korea
        • Recruiting
        • Kangbuk Samsung Hospital
        • Contact:
          • Byung-jin Kim, MD
        • Principal Investigator:
          • Byung-jin Kim, MD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
          • Woo-young Chung, MD
        • Principal Investigator:
          • Woo-young Chung, MD
      • Seoul, South Korea
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Hyuck-moon Kwon, MD
        • Principal Investigator:
          • Hyuck-moon Kwon, MD
      • Seoul, South Korea
        • Recruiting
        • Kangdong Sacred Heart Hospital
        • Contact:
          • Kyoo-rok Han, MD
        • Principal Investigator:
          • Kyoo-rok Han, MD
      • Seoul, South Korea
        • Recruiting
        • Dongguk University Medical Center
        • Contact:
          • Deuk-young Nah, MD
        • Principal Investigator:
          • Deuk-young Nah, MD
      • Seoul, South Korea
        • Terminated
        • 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
      • Suwon, South Korea
        • Recruiting
        • The Catholic university of Korea, St. Vincent's Hospital
        • Contact:
          • Keon-woong Moon, MD
        • Principal Investigator:
          • Keon-woong Moon, MD
      • Suwon, South Korea
        • Terminated
        • Ajou University Hospital
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:
          • Sang-Gon Lee, MD, PhD
        • Principal Investigator:
          • Sang-Gon Lee, MD, PhD
      • Wŏnju, South Korea
        • Recruiting
        • Wonju Christian Hospital
        • Contact:
          • Junghan Yoon
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Shin Kong Hospital
        • Contact:
          • Jun-Jack Cheng
  • Thailand
      • Bangkok, Thailand
        • Recruiting
        • Siriraj Hospital
        • Contact:
          • D. Tresukosol
        • Principal Investigator:
          • D. Tresukosol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Left Main disease
Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event
Time Frame: 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.
2-year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Investigators

  • Principal Investigator: Seung-Jung Park, MD, PhD, CVRF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2007

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

April 22, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimated)

April 25, 2011

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVRF2010-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not a publicly funded trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe