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NCT Number: NCT01341327

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Shanghai, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Death

    Time frame: 10-year

  2. Cardiac death

    Time frame: 10-year

  3. Myocardial infarction

    Time frame: 10-year

  4. Cerebrovascular event

    Time frame: 10-year

  5. Target vessel revascularization

    Time frame: 10-year

  6. Target lesion revascularization

    Time frame: 10-year

  7. Stent thrombosis

    Time frame: 10-year

    According to Academic Research Consortium (ARC) criteria

  8. 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. Rehospitalization

    Time frame: 10-year

Study contacts

Contact information is provided by the study sponsor or research team.

Seung-Jung Park, MD, PhD

CONTACT

[email protected]

82-2-3010-3152

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS-MAIN

Important dates

Study start
2007
Primary completion
2032
Study completion
2033
First posted
Apr 25, 2011
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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