RecruitingNCT01341327IRIS-MAINUpdated Mar 20, 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 2026-03-20.

Sponsored by Seung-Jung Park · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 10,000
Ages: 18 Years and older
Sex: All

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

Conditions studied

Coronary Artery Disease

Browse trials for

Coronary Artery Disease 5,581

Keywords

Left Main

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.

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

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.

What researchers measure

Primary outcomes

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

Secondary outcomes

Death
Time frame: 10-year
Cardiac death
Time frame: 10-year
Myocardial infarction
Time frame: 10-year
Cerebrovascular event
Time frame: 10-year
Target vessel revascularization
Time frame: 10-year
Target lesion revascularization
Time frame: 10-year
Stent thrombosis
According to Academic Research Consortium (ARC) criteria
Time frame: 10-year
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
Rehospitalization
Time frame: 10-year

Study locations

28 of 42 sites recruiting

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

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

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: Mar 20, 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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