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Observational Study for Left Main Disease Treatment

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01341327
Acronym
IRIS-MAIN
Enrollment
10000
Registered
2011-04-25
Start date
2007-07-01
Completion date
2033-12-01
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Left Main

Brief 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.

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

Interventions

None listed

Sponsors

Seung-Jung Park
Lead SponsorOTHER
CardioVascular Research Foundation, Korea
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event2-yearA 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

MeasureTime frameDescription
Death10-year
Cardiac death10-year
Myocardial infarction10-year
Cerebrovascular event10-year
Target vessel revascularization10-year
Target lesion revascularization10-year
Stent thrombosis10-yearAccording to Academic Research Consortium (ARC) criteria
Binary restenosis and late luminal loss in both in-stent and in-segment9-monthAngiographic follow-up in the PCI group (as form of PCI substudy)
Rehospitalization10-year

Countries

China, Malaysia, South Korea, Taiwan, Thailand

Contacts

CONTACTSeung-Jung Park, MD, PhD
sjpark@amc.seoul.kr82-2-3010-3152
PRINCIPAL_INVESTIGATORSeung-Jung Park, MD, PhD

CVRF

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026