IRIS-Onyx Cohort in the IRIS-DES Registry

Recruiting

• Conditions: Coronary Artery Disease; Arterial Occlusive Diseases; Cardiovascular Diseases; Percutaneous Transluminal Angioplasty

• Registration Number: NCT02593994
• Lead Sponsor: Seung-Jung Park

Brief Summary

The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

• Age 19 and more
• Intervention with Onyx Drug Eluting Stent
• Agreed with written informed consent form

Exclusion Criteria

• Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time
• Life expectancy of 1year and under
• Cardiac shock

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent thrombosis	1 year	As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis

Secondary Outcome Measures

Name	Time	Method
Composite event rate	5 year	death, myocardial infarction, target vessel revascularization
Target Lesion revascularization	5 year
Myocardial infarction	5 year
Cardiac death	5 year
Procedural success	3 day	defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days.
Target Vessel revascularization	5 year
Stent thrombosis	5 year
Composite event of death or myocardial infarction	5 year
Composite event of cardiac death or myocardial infarction	5 year
All death	5 year
Stroke	5 year

Trial Locations

Locations (33)

The Catholic University of Korea, Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Republic Of Korea, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

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