AzTrials
AzTrials

Coronary Artery DiseaseIRIS-MAINNCT01341327

Observational Study for Left Main Disease Treatment

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 42 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
10,000 participants
Where
42 sitesin 5 countries
Study dates
Jul 2007to Dec 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Protected left main stenosis

Trial locations and contacts

42 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Seung-Jung Park, MD, PhD contact

82-2-3010-3152

sjpark@amc.seoul.kr

42 sites in 5 countries

South Korea38 sites, 24 recruiting

  • Hallym University medical center

    Anyang

    Woo-jung Park, MD

    woo-jung Park, MD

    Recruiting

  • Soonchunhyang University Hospital, Buchen

    Bucheon-si

    Terminated

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

    Bucheon-si

    Terminated

  • Inje University Busan Paik Hospital

    Busan

    Tae-hyun Yang, MD

    Tae-hyun Yang, MD

    Recruiting

  • Soonchunhyang University Hospital, Cheonan

    Cheonan

    Won Yong Shin

    Recruiting

  • St.Mary's Catholic Medical Center

    Cheongju-si

    Terminated

  • Daegu Catholic University Medical Center

    Daegu

    Kee-sik Kim, MD

    Kee-sik Kim, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Seung-ho Hur, MD

    Seung-ho Hur, MD

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Terminated

  • Chungnam National University Hospital

    Daejeon

    Jin-ok Jeong, MD

    Jin-ok Jeong, MD

    Recruiting

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

    Daejeon

    Terminated

  • Gangneung Asan Medical Center

    Gangneung

    Sang-sig Cheong, MD

    Sang-sig Cheong, MD

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Myung-ho Jeong, MD

    Myung-ho Jeong, MD

    Recruiting

  • National Health Insurance Service Ilsan Hospital

    Ilsan

    Terminated

  • St.Mary's Catholic Medical Center

    Inchon

    Terminated

  • Chonbuk National University Hospital

    Jeonju

    Jei-keon Chae, MD

    Jei-keon Chae, MD

    Recruiting

  • Presbyterian Medical Center

    Jeonju

    Jay-young Rhew, MD

    Jay-young Rhew, MD

    Recruiting

  • Kwangju Christian hospital

    Kwangju

    Seung-uk Lee, MD

    Seung-uk Lee, MD

    Recruiting

  • Pusan Natioanal University Hospital

    Pusan

    June-Hong Kim, MD, PhD

    June-Hong Kim, MD, PhD

    Recruiting

  • Bundang CHA Hospital

    Seongnam

    Terminated

  • Asan Medical Center

    Seoul, 138-736

    Seung-jung Park, MD, sjpark@amc.seoul.kr

    Seung-jung Park, MD

    Recruiting

  • Dongguk University Medical Center

    Seoul

    Deuk-young Nah, MD

    Deuk-young Nah, MD

    Recruiting

  • Gangnam Severance Hospital

    Seoul

    Hyuck-moon Kwon, MD

    Hyuck-moon Kwon, MD

    Recruiting

  • Kangbuk samsung hospital

    Seoul

    Byung-jin Kim, MD

    Byung-jin Kim, MD

    Recruiting

  • Kangdong Sacred Heart Hospital

    Seoul

    Kyoo-rok Han, MD

    Kyoo-rok Han, MD

    Recruiting

  • Korea University Anam hospital

    Seoul

    Do-sun Lim, MD

    Do-sun Lim, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Seung-un Na, MD

    Seung-un Na, MD

    Recruiting

  • Seoul National University Boramae Medical Center

    Seoul

    Woo-young Chung, MD

    Woo-young Chung, MD

    Recruiting

  • Seoul National University Hospital

    Seoul

    Hyo-Soo Kim, MD, PhD

    Hyo-Soo Kim, MD, PhD

    Recruiting

  • Seoul Veterans Hospital

    Seoul

    Terminated

  • St.Mary's Catholic Medical Center

    Seoul

    Terminated

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

    Seoul

    Terminated

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

    Seoul

    Terminated

  • Yonsei University Medical Center

    Seoul

    Terminated

  • Ajou University Hospital

    Suwon

    Terminated

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

    Suwon

    Keon-woong Moon, MD

    Keon-woong Moon, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Sang-Gon Lee, MD, PhD

    Sang-Gon Lee, MD, PhD

    Recruiting

  • Wonju Christian Hospital

    Wŏnju

    Junghan Yoon

    Recruiting

Other trials in South Korea

China1 site, 1 recruiting

  • Zhongshan Hospital

    Shanghai

    Junbo Ge

    Recruiting

Other trials in China

Malaysia1 site, 1 recruiting

  • Sarawak General Hospital

    Kuching

    K.H. Shim

    K.H. Shim

    Recruiting

Other trials in Malaysia

Taiwan1 site, 1 recruiting

  • Shin Kong Hospital

    Taipei

    Jun-Jack Cheng

    Recruiting

Other trials in Taiwan

Thailand1 site, 1 recruiting

  • Siriraj Hospital

    Bangkok

    D. Tresukosol

    D. Tresukosol

    Recruiting

Other trials in Thailand

About this study

Official title: 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.

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

Keywords
Left Main
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01341327
Study groupRoleWhat they receive
Left Main diseaseConsecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    Measured: 10-year

Secondary outcomes (9)

  1. Cardiac death

    Measured: 10-year

  2. Myocardial infarction

    Measured: 10-year

  3. Cerebrovascular event

    Measured: 10-year

  4. Target vessel revascularization

    Measured: 10-year

  5. Target lesion revascularization

    Measured: 10-year

  6. Stent thrombosis

    According to Academic Research Consortium (ARC) criteria

    Measured: 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)

    Measured: 9-month

  8. Rehospitalization

    Measured: 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.

    Measured: 2-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2011 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2032 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01341327
Sponsor's protocol ID
CVRF2010-08
Acronym
IRIS-MAIN
Status last verified
Oct 2026
First submitted
22 Apr 2011
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: This is not a publicly funded trial

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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 42 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in South Korea, China, Malaysia, Taiwan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seung-Jung Park, MD, PhD (82-2-3010-3152, sjpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: 10-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01341327, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Observational Study for Left Main Disease Treatment | AzTrials