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

Recruiting

• Conditions: Atherosclerotic heart disease of native coronary artery, Left Main coronary disease,

• Registration Number: CTRI/2013/05/003681
• Lead Sponsor: SeungJung Park

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-29
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• •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.

Exclusion Criteria

•Protected left main stenosis.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is measured in terms of major cardiac and cerebrovascular event (MACCE)-free survival at two year follow-up after index treatment.	2year
ï‚ŸNon-fatal myocardial infarction (Q wave and non-Q wave)	2year
ï‚ŸTarget vessel revascularization (TVR) either percutaneous or surgical treatment	2year
ï‚ŸDeath (all-cause mortality)	2year
ï‚ŸStroke	2year

Secondary Outcome Measures

Name	Time	Method
ï‚ŸAll cause death.	ï‚ŸCardiac death.

Trial Locations

Locations (1)

Ruby Hall clinic; 🇮🇳 Pune, MAHARASHTRA, India

Ruby Hall clinic

🇮🇳Pune, MAHARASHTRA, India

Dr Vaishali Jadhav

Principal investigator

91-9763310407

vaishalishelekar@gmail.com