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History of Changes for Study: NCT01341327
Multicenter, Prospective Observational Study for Left Main Disease Treatment (IRIS-MAIN)
Latest version (submitted April 3, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 22, 2011 None (earliest Version on record)
2 May 3, 2011 Study Status
3 August 7, 2012 Sponsor/Collaborators, Groups and Interventions, Study Status, Study Design, Study Description and Study Identification
4 November 10, 2015 Study Status and Sponsor/Collaborators
5 December 14, 2015 Study Status and Sponsor/Collaborators
6 June 21, 2016 Study Status and IPDSharing
7 July 19, 2017 Study Status and Study Design
8 December 20, 2018 Contacts/Locations and Study Status
9 January 28, 2020 Contacts/Locations and Study Status
10 December 16, 2020 Study Status
11 September 6, 2021 Study Status and Outcome Measures
12 December 8, 2022 Study Status and Contacts/Locations
13 April 3, 2023 Study Status and Contacts/Locations
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Study NCT01341327
Submitted Date:  April 22, 2011 (v1)
Open or close this module Study Identification
Unique Protocol ID: CVRF2010-08
Brief Title: Multicenter, Prospective Observational Study for Left Main Disease Treatment (IRIS-MAIN)
Official Title: A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2007
Overall Status: Recruiting
Study Start: July 2007
Primary Completion: July 2017 [Anticipated]
Study Completion: July 2019 [Anticipated]
First Submitted: April 22, 2011
First Submitted that
Met QC Criteria:		 April 22, 2011
First Posted: April 25, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:		 April 22, 2011
Last Update Posted: April 25, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: CardioVascular Research Foundation, Korea
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Coronary Artery Disease
Keywords: Left Main
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 3000 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
IRIS MAIN
 Procedure: PCI
PCI with any DES

Procedure: CABG
Coronary artery bypass graft surgery

Procedure: Medication
optimal medication only
Open or close this module Outcome Measures
Open or close this module Eligibility
Study Population: Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Seung-Jung Park, MD, PhD
Telephone: 82-2-3010-3152
Email: sjpark@amc.seoul.kr
Study Officials: Seung-Jung Park, MD, PhD
Principal Investigator
CVRF
Locations: China
Zhongshan Hospital
[Recruiting]
Shanghai, China
Contact:Contact: Junbo Ge
Korea, Republic of
Soonchunhyang University Hospital, Buchen
[Recruiting]
Bucheon, Korea, Republic of
Contact:Contact: Nae Hee Lee
The Catholic University of Korea, Bucheon ST.Mary's Hospital
[Recruiting]
Bucheon, Korea, Republic of
Contact:Contact: Hee-Yeol Kim
Soonchunhyang University Hospital, Cheonan
[Recruiting]
Cheonan, Korea, Republic of
Contact:Contact: Won Yong Shin
St.Mary's Catholic Medical Center
[Recruiting]
Cheongju, Korea, Republic of
Contact:Contact: Yong-Mo Yang, MD, PhD
Contact:Principal Investigator: Yong-Mo Yang, MD, PhD
The Catholic University of Korea, Daejeon ST.Mary's Hospital
[Recruiting]
Daejeon, Korea, Republic of
Contact:Contact: Sung Ho Hur
St.Mary's Catholic Medical Center
[Recruiting]
Inchon, Korea, Republic of
Contact:Contact: Doo Soo Jeon, MD, PhD
Contact:Contact: MJ Kim, MD, PhD
Contact:Principal Investigator: Doo Soo Jeon, MD, PhD
Pusan Natioanal University Hospital
[Recruiting]
Pusan, Korea, Republic of
Contact:Contact: June-Hong Kim, MD, PhD
Contact:Principal Investigator: June-Hong Kim, MD, PhD
Bundang CHA Hospital
[Recruiting]
Seongnam, Korea, Republic of
Contact:Contact: S.W Lim, MD
Contact:Principal Investigator: S.W. Lim, MD
Cardio Vascular Research Foundation
[Recruiting]
Seoul, Korea, Republic of, 138-736
Contact:Contact: Eun-Young Kim 82-2-3010-7393 cvcrc@amc.seoul.kr
Seoul National University Hospital
[Recruiting]
Seoul, Korea, Republic of
Contact:Contact: Hyo-Soo Kim, MD, PhD
Contact:Principal Investigator: Hyo-Soo Kim, MD, PhD
Seoul Veterans Hospital
[Recruiting]
Seoul, Korea, Republic of
Contact:Contact: Keun Lee
St.Mary's Catholic Medical Center
[Recruiting]
Seoul, Korea, Republic of
Contact:Contact: Ki Bae Seung, MD, PhD
Contact:Principal Investigator: Ki Bae Seung, MD, PhD
The Catholic University of Korea, Kangnam ST.Mary's Hospital
[Recruiting]
Seoul, Korea, Republic of
Contact:Contact: Ki-Bae Seung, MD,PhD
Yonsei University Medical Center
[Recruiting]
Seoul, Korea, Republic of
Contact:Contact: YangSoo Jang, MD, PhD
Contact:Principal Investigator: YangSoo Jang, MD, PhD
Ajou University Hospital
[Recruiting]
Suwon, Korea, Republic of
Contact:Contact: Seung-Jae Tahk, MD, PhD
Contact:Principal Investigator: Seung-Jae Tahk, MD, PhD
Ulsan University Hospital
[Recruiting]
Ulsan, Korea, Republic of
Contact:Contact: Sang-Gon Lee, MD, PhD
Contact:Principal Investigator: Sang-Gon Lee, MD, PhD
Wonju Christian Hospital
[Recruiting]
Wonju, Korea, Republic of
Contact:Contact: Junghan Yoon
Malaysia
Sarawak General Hospital
[Recruiting]
Kuching, Malaysia
Contact:Contact: K.H. Shim
Contact:Principal Investigator: K.H. Shim
Taiwan
Shin Kong Hospital
[Recruiting]
Taipei, Taiwan
Contact:Contact: Jun-Jack Cheng
Thailand
Siriraj Hospital
[Recruiting]
Bangkok, Thailand
Contact:Contact: D. Tresukosol
Contact:Principal Investigator: D. Tresukosol
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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