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RecruitingNCT01341327IRIS-MAINUpdated Oct 15, 2026

Observational Study for Left Main Disease Treatment

An observational study in Coronary Artery Disease, sponsored by Seung-Jung Park. Recruiting at 42 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Seung-Jung Park · Observational

From the registry’s dates

  • Started Jul 2007; still recruiting 19 years 4 months later.
Updated Oct 15, 2026Primary outcomes revisedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Left Main
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Protected left main stenosis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • Left Main disease

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

06

What researchers measure

Primary outcomes

  1. Death

    Time frame: 10-year

Secondary outcomes

  1. Cardiac death

    Time frame: 10-year

  2. Myocardial infarction

    Time frame: 10-year

  3. Cerebrovascular event

    Time frame: 10-year

  4. Target vessel revascularization

    Time frame: 10-year

  5. Target lesion revascularization

    Time frame: 10-year

  6. Stent thrombosis

    According to Academic Research Consortium (ARC) criteria

    Time frame: 10-year

  7. 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)

    Time frame: 9-month

  8. Rehospitalization

    Time frame: 10-year

  9. 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.

    Time frame: 2-year

07

Study locations

28 of 42 sites recruiting
  • Zhongshan Hospital
    Shanghai, China
    Recruiting
    • Junbo Ge · Contact
  • Sarawak General Hospital
    Kuching, Malaysia
    Recruiting
    • K.H. Shim · Contact
    • K.H. Shim · Principal investigator
  • Hallym University medical center
    Anyang, South Korea
    Recruiting
    • Woo-jung Park, MD · Contact
    • woo-jung Park, MD · Principal investigator
  • Soonchunhyang University Hospital, Buchen
    Bucheon-si, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • The Catholic University of Korea, Bucheon ST.Mary's Hospital
    Bucheon-si, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Inje University Busan Paik Hospital
    Busan, South Korea
    Recruiting
    • Tae-hyun Yang, MD · Contact
    • Tae-hyun Yang, MD · Principal investigator
  • Soonchunhyang University Hospital, Cheonan
    Cheonan, South Korea
    Recruiting
    • Won Yong Shin · Contact
  • St.Mary's Catholic Medical Center
    Cheongju-si, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Daegu Catholic University Medical Center
    Daegu, South Korea
    Recruiting
    • Kee-sik Kim, MD · Contact
    • Kee-sik Kim, MD · Principal investigator
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    Recruiting
    • Seung-ho Hur, MD · Contact
    • Seung-ho Hur, MD · Principal investigator
  • Yeungnam University Medical Center
    Daegu, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Chungnam National University Hospital
    Daejeon, South Korea
    Recruiting
    • Jin-ok Jeong, MD · Contact
    • Jin-ok Jeong, MD · Principal investigator
  • The Catholic University of Korea, Daejeon ST.Mary's Hospital
    Daejeon, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Gangneung Asan Medical Center
    Gangneung, South Korea
    Recruiting
    • Sang-sig Cheong, MD · Contact
    • Sang-sig Cheong, MD · Principal investigator
  • Chonnam National University Hospital
    Gwangju, South Korea
    Recruiting
    • Myung-ho Jeong, MD · Contact
    • Myung-ho Jeong, MD · Principal investigator
  • National Health Insurance Service Ilsan Hospital
    Ilsan, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • St.Mary's Catholic Medical Center
    Inchon, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Chonbuk National University Hospital
    Jeonju, South Korea
    Recruiting
    • Jei-keon Chae, MD · Contact
    • Jei-keon Chae, MD · Principal investigator
  • Presbyterian Medical Center
    Jeonju, South Korea
    Recruiting
    • Jay-young Rhew, MD · Contact
    • Jay-young Rhew, MD · Principal investigator
  • Kwangju Christian hospital
    Kwangju, South Korea
    Recruiting
    • Seung-uk Lee, MD · Contact
    • Seung-uk Lee, MD · Principal investigator
  • Pusan Natioanal University Hospital
    Pusan, South Korea
    Recruiting
    • June-Hong Kim, MD, PhD · Contact
    • June-Hong Kim, MD, PhD · Principal investigator
  • Bundang CHA Hospital
    Seongnam, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Asan Medical Center
    Seoul, 138-736, South Korea
    Recruiting
    • Seung-jung Park, MD · Contactsjpark@amc.seoul.kr
    • Seung-jung Park, MD · Principal investigator
  • Dongguk University Medical Center
    Seoul, South Korea
    Recruiting
    • Deuk-young Nah, MD · Contact
    • Deuk-young Nah, MD · Principal investigator
  • Gangnam Severance Hospital
    Seoul, South Korea
    Recruiting
    • Hyuck-moon Kwon, MD · Contact
    • Hyuck-moon Kwon, MD · Principal investigator
  • Kangbuk samsung hospital
    Seoul, South Korea
    Recruiting
    • Byung-jin Kim, MD · Contact
    • Byung-jin Kim, MD · Principal investigator
  • Kangdong Sacred Heart Hospital
    Seoul, South Korea
    Recruiting
    • Kyoo-rok Han, MD · Contact
    • Kyoo-rok Han, MD · Principal investigator
  • Korea University Anam hospital
    Seoul, South Korea
    Recruiting
    • Do-sun Lim, MD · Contact
    • Do-sun Lim, MD · Principal investigator
  • Korea University Guro Hospital
    Seoul, South Korea
    Recruiting
    • Seung-un Na, MD · Contact
    • Seung-un Na, MD · Principal investigator
  • Seoul National University Boramae Medical Center
    Seoul, South Korea
    Recruiting
    • Woo-young Chung, MD · Contact
    • Woo-young Chung, MD · Principal investigator
  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting
    • Hyo-Soo Kim, MD, PhD · Contact
    • Hyo-Soo Kim, MD, PhD · Principal investigator
  • Seoul Veterans Hospital
    Seoul, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • St.Mary's Catholic Medical Center
    Seoul, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • The Catholic University of Korea, ST. Paul's Hospital
    Seoul, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital
    Seoul, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Yonsei University Medical Center
    Seoul, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • Ajou University Hospital
    Suwon, South Korea
    Terminated

    Not enrolling at this site — choose another above.

  • The Catholic University of Korea, ST. Vincent's Hospital
    Suwon, South Korea
    Recruiting
    • Keon-woong Moon, MD · Contact
    • Keon-woong Moon, MD · Principal investigator
  • Ulsan University Hospital
    Ulsan, South Korea
    Recruiting
    • Sang-Gon Lee, MD, PhD · Contact
    • Sang-Gon Lee, MD, PhD · Principal investigator
  • Wonju Christian Hospital
    Wŏnju, South Korea
    Recruiting
    • Junghan Yoon · Contact
  • Shin Kong Hospital
    Taipei, Taiwan
    Recruiting
    • Jun-Jack Cheng · Contact
  • Siriraj Hospital
    Bangkok, Thailand
    Recruiting
    • D. Tresukosol · Contact
    • D. Tresukosol · Principal investigator
08

References and documents

Publications

  • 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. PubMed 38199751 ↗
  • 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. PubMed 35907438 ↗
  • 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. PubMed 34233836 ↗
  • 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. PubMed 32943156 ↗
  • 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. PubMed 28701487 ↗

Individual participant data

Plan to share: No — This is not a publicly funded trial

09

Updates

1 registry update since Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular eventNow DeathTime frame: 2-year → 10-year
Oct 15, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore DeathNow Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular eventTime frame: 10-year → 2-year
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular eventNow DeathTime frame: 2-year → 10-year
    Secondary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore DeathNow Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular eventTime frame: 10-year → 2-year
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01341327
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea) — Sponsor-investigator
First posted
Apr 25, 2011
Start date
Jul 2007
Primary completion
Dec 2032 (estimated)
Completion
Dec 2033 (estimated)
Last update
Oct 15, 2026

Study contacts

Seung-Jung Park, MD, PhD
Contact
sjpark@amc.seoul.kr
82-2-3010-3152
Seung-Jung Park, MD, PhD
principal investigator · CVRF

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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