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CTRI Number  CTRI/2013/05/003681 [Registered on: 27/05/2013] Trial Registered Retrospectively
Last Modified On: 04/02/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT(IRIS MAIN) 
Scientific Title of Study   A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT 
Trial Acronym  IRIS MAIN 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT01341327  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shirish Hiremath 
Designation  Interventional Cardiologist  
Affiliation  Ruby Hall Clinic, Pune 
Address  Cardiac OPD 7 Ground floor,Ruby Hall Clinic

Pune
MAHARASHTRA
411001
India 
Phone  020-66455376  
Fax  020-66455376  
Email  shirish.hiremath@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vaishali Jadhav 
Designation  Clinical Research Coordinator 
Affiliation  Ruby Hall Clinic, Pune 
Address  Cardiac OPD 7 Ground floor,Ruby Hall Clinic

Pune
MAHARASHTRA
411001
India 
Phone  919763310407  
Fax  020-66455376  
Email  vaishalishelekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Reshma Pawar 
Designation  Clinical Data Manager 
Affiliation  Heart Institute, Asan Medical Center, CardioVascular Research Foundation 
Address  Cardiac OPD 7 Ground floor,Ruby Hall Clinic

Pune
MAHARASHTRA
411001
India 
Phone  91-9405868870  
Fax  020-66455376  
Email  reshmami_78@rediffmail.com  
 
Source of Monetary or Material Support  
CardioVascular Research Foundation Seoul 
 
Primary Sponsor  
Name  SeungJung Park 
Address  Asan Medical Center CardioVascular Clinical Research Center 88, Olympic-Ro 43-Gil, Songpa-Gu, Seoul 138-736, KOREA  
Type of Sponsor  Other [Sponsor-investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Indonesia
Japan
Malaysia
Taiwan
Thailand
Republic of Korea  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishali Jadhav  Ruby Hall clinic   40, Sasoon Road, B S Dhole Patil Path, Pune, Maharashtra
Pune
MAHARASHTRA 		 91-9763310407
91-020-66455376
vaishalishelekar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Fortis Escorts Heart Institute  Approved 
POONA MEDICAL RESEARCH FOUNDATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, Left Main coronary disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  •Significant unprotected left main stenosis (>50% by visual estimation)

â—¦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.
 
 
ExclusionCriteria 
Details  •Protected left main stenosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective is measured in terms of major cardiac and cerebrovascular event (MACCE)-free survival at two year follow-up after index treatment.
ï‚Ÿ Death (all-cause mortality)
ï‚Ÿ Stroke
ï‚Ÿ Non-fatal myocardial infarction (Q wave and non-Q wave)
ï‚Ÿ Target vessel revascularization (TVR) either percutaneous or surgical treatment
 		 2year 
 
Secondary Outcome  
Outcome  TimePoints 
ï‚Ÿ All cause death.
ï‚Ÿ Cardiac death.
ï‚Ÿ Myocardial infarction.
ï‚Ÿ Stroke.
ï‚Ÿ Target-vessel revascularization.
ï‚Ÿ Target-lesion revascularization.
ï‚Ÿ Stent thrombosis in the PCI group.
ï‚Ÿ Binary restenosis and late luminal loss in both in-stent and in-segment at 9 month angiographic follow-up in the PCI group (as form of PCI substudy).
ï‚Ÿ Any re-hospitalization with a cardiac cause
 		 10year 
 
Target Sample Size
Modification(s)  		 Total Sample Size="10000"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/06/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/08/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="12"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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 10000 subjects who diagnosed LM disease (>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region.

 

The primary objective 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. 

 

 
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