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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Arterial Occlusive Diseases; Percutaneous Transluminal Angioplasty
• Intervention / Treatment: Device: Onyx Drug Eluting Stent group

• Study Type: Observational
• Enrollment (Actual): 4500

Contacts and Locations

Study Locations

• South Korea
  • Anyang, South Korea
    • Hallym University Sacred Heart Hospital
  • Bucheon-si, South Korea
    • Soon Chun Hyang University Hospital Bucheon
  • Cheonan, South Korea
    • Soon Chun Hyang University Hospital Cheonan
  • Chuncheon, South Korea
    • Gangwon National Univ. Hospital
  • Daegu, South Korea
    • Keimyung University Dongsan Medical Center
  • Daegu, South Korea
    • Daegu Catholic University Medical Center
  • Daejeon, South Korea
    • Chungnam National University Hospital
  • Daejeon, South Korea
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gangneung, South Korea
    • GangNeung Asan Hospital
  • Gwangju, South Korea
    • Chonnam National University Hospital
  • Ilsan, South Korea
    • Inje University Ilsan Paik Hospital
  • Jeonju, South Korea
    • Presbyterian Medical Center
  • Kwangju, South Korea
    • Kwangju Christian hospital
  • Pusan, South Korea
    • Inje University Pusan Paik Hospital
  • Pusan, South Korea
    • Pusan National University Hospital
  • Pusan, South Korea
    • Dong-A Medical Center
  • Seongnam, South Korea
    • Bundang CHA Hospital
  • Seoul, South Korea
    • Kangbuk Samsung Hospital
  • Seoul, South Korea
    • Korea University Anam Hospital
  • Seoul, South Korea
    • Korea University Guro Hospital
  • Seoul, South Korea
    • Gangnam Severance Hospital
  • Seoul, South Korea
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Seoul, South Korea
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, South Korea
    • The Catholic University of Korea St. Paul's Hospital
  • Seoul, South Korea
    • Kangdong Sacred Heart Hospital
  • Suncheon, South Korea
    • St.carollo Hospital
  • Ulsan, South Korea
    • Ulsan University Hospital
  • Wŏnju, South Korea
    • Wonju Severance Christian Hospital
  • Yangsan, South Korea
    • Pusan National University Yangsan Hospital
  • Republic of Korea
    • Seoul, Republic of Korea, South Korea
      • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, South Korea, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with Onyx Drug Eluting Stent

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Onyx Drug Eluting Stent	Device: Onyx Drug Eluting Stent group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent thrombosis	As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		5 year
Myocardial infarction		5 year
Stent thrombosis		5 year
Stroke		5 year
All death		5 year
Composite event of death or myocardial infarction		5 year
Composite event of cardiac death or myocardial infarction		5 year
Composite event rate	death, myocardial infarction, target vessel revascularization	5 year
Target Vessel revascularization		5 year
Target Lesion revascularization		5 year
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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea; Medtronic Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimated): November 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Routine Clinical Practice; Angioplasty, Transluminal, Percutaneous Coronary; drug eluting stent; Onyx
• Additional Relevant MeSH Terms: Vascular Diseases; Heart Diseases; Arteriosclerosis; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease; Arterial Occlusive Diseases
• Other Study ID Numbers: AMCCV2015-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.