IRIS-Onyx Cohort in the IRIS-DES Registry
IRIS-Onyx
Evaluation of Effectiveness and Safety of Resolute Onyx™ and Onyx Frontier™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
1 other identifier
observational
4,500
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 30, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
January 15, 2026
January 1, 2026
11.3 years
October 30, 2015
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stent thrombosis
As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis
1 year
Secondary Outcomes (11)
All death
5 year
Cardiac death
5 year
Myocardial infarction
5 year
Composite event of death or myocardial infarction
5 year
Composite event of cardiac death or myocardial infarction
5 year
- +6 more secondary outcomes
Study Arms (1)
Onyx Drug Eluting Stent
Interventions
Eligibility Criteria
patients with Onyx Drug Eluting Stent
You may qualify if:
- Age 19 and more
- Intervention with Onyx Drug Eluting Stent
- Agreed with written informed consent form
You may not qualify if:
- Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
- Medtronic Korea Co., Ltd.collaborator
Study Sites (31)
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Republic of Korea, South Korea
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Presbyterian Medical Center
Jeonju, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
Dong-A Medical Center
Pusan, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Pusan National University Hospital
Pusan, South Korea
Bundang CHA Hospital
Seongnam, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Kangdong Sacred Heart Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea St. Paul's Hospital
Seoul, South Korea
St.carollo Hospital
Suncheon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 30, 2015
First Posted
November 2, 2015
Study Start
October 1, 2015
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2030
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
This is not a publicly funded trial.