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NCT02593994 Clinical Trial

IRIS-Onyx Cohort in the IRIS-DES Registry

Coronary Artery Disease Clinical Trial

— IRIS-Onyx  

Official title:
Evaluation of Effectiveness and Safety of Resolute Onyx™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02593994
Other study ID # AMCCV2015-04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2015
Est. completion date December 31, 2029

Study information
Verified date December 2023
Source Asan Medical Center
Contact Seung-jung Park, MD, PhD
Email sjpark@amc.seoul.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 4500
Est. completion date December 31, 2029
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Onyx Drug Eluting Stent group

Locations
Country Name City State
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 Gangneung Asan Hospital Gangneung
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Inje University Ilsan Paik Hospital Ilsan
Korea, Republic of Gachon University Gil Hospital Incheon
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of Presbyterian Medical Center Jeonju
Korea, Republic of Kwangju Christian Hospital Kwangju
Korea, Republic of Dong-A Medical Center Pusan
Korea, Republic of Inje University Pusan Paik Hospital Pusan
Korea, Republic of Pusan National University Hospital Pusan
Korea, Republic of Bundang CHA Hospital Seongnam
Korea, Republic of Asan Medical Center Seoul Songpa-gu
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Kangdong Sacred Heart Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea St. Paul's Hospital Seoul
Korea, Republic of The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul Republic Of Korea
Korea, Republic of St.carollo Hospital Suncheon
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Wonju Severance Christian Hospital Wonju
Korea, Republic of Pusan National University Yangsan Hospital Yangsan

Sponsors (3)
Lead Sponsor Collaborator
Seung-Jung Park CardioVascular Research Foundation, Korea, Medtronic Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stent thrombosis As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis 1 year
Secondary All death 5 year
Secondary Cardiac death 5 year
Secondary Myocardial infarction 5 year
Secondary Composite event of death or myocardial infarction 5 year
Secondary Composite event of cardiac death or myocardial infarction 5 year
Secondary Composite event rate death, myocardial infarction, target vessel revascularization 5 year
Secondary Target Vessel revascularization 5 year
Secondary Target Lesion revascularization 5 year
Secondary Stent thrombosis 5 year
Secondary Stroke 5 year
Secondary Procedural success 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. 3 day
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