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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CardioVascular Research Foundation, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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