Observational Study for Left Main Disease Treatment (IRIS-MAIN)

• ClinicalTrials.gov Identifier: NCT01341327
• Recruitment Status: Recruiting
• First Posted: April 25, 2011
• Last Update Posted: April 4, 2023
• Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea
• Information provided by (Responsible Party): Seung-Jung Park, CardioVascular Research Foundation, Korea

Tracking Information

• First Submitted Date: April 22, 2011
• First Posted Date: April 25, 2011
• Last Update Posted Date: April 4, 2023
• Actual Study Start Date: July 2007
• Estimated Primary Completion Date: December 2032 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2021)

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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: September 6, 2021)

• 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 [ Time Frame: 10-year ]
  According to Academic Research Consortium (ARC) criteria
• 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)
• Rehospitalization [ Time Frame: 10-year ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Observational Study for Left Main Disease Treatment
• Official Title: A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT
• 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
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.
• Condition: Coronary Artery Disease
• Intervention: Not Provided

Study Groups/Cohorts

Left Main disease

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

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 19, 2017): 10000
• Original Estimated Enrollment (submitted: April 22, 2011): 3000
• Estimated Study Completion Date: December 2033
• Estimated Primary Completion Date: December 2032 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Seung-Jung Park, MD, PhD; 82-2-3010-3152; sjpark@amc.seoul.kr

• Listed Location Countries: China, Korea, Republic of, Malaysia, Taiwan, Thailand

Administrative Information

• NCT Number: NCT01341327
• Other Study ID Numbers: CVRF2010-08
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: This is not a publicly funded trial

• Current Responsible Party: Seung-Jung Park, CardioVascular Research Foundation, Korea
• Original Responsible Party: Clinical Research Center, Asan Medical Center
• Current Study Sponsor: Seung-Jung Park
• Original Study Sponsor: CardioVascular Research Foundation, Korea
• Collaborators: CardioVascular Research Foundation, Korea

Investigators

• Principal Investigator: Seung-Jung Park, MD, PhD; CVRF

• PRS Account: CardioVascular Research Foundation, Korea
• Verification Date: April 2023