IRIS-Onyx Cohort in the IRIS-DES Registry (IRIS-Onyx)

Evaluation of Effectiveness and Safety of Resolute Onyx™ 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: 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 (Estimated): 4500

Contacts and Locations

• Study Contact: Name: Seung-jung Park, MD, PhD; Email: sjpark@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Recruiting
    • Hallym University Sacred Heart Hospital
    • Contact: Hyun-Sook Kim, MD
    • Principal Investigator: Hyun-Sook Kim, MD
  • Bucheon, Korea, Republic of
    • Recruiting
    • Soon Chun Hyang University Hospital Bucheon
    • Contact: Nae-Hee Lee, MD
    • Principal Investigator: Nae-Hee Lee, MD
  • Cheonan, Korea, Republic of
    • Recruiting
    • Soon Chun Hyang University Hospital Cheonan
    • Contact: Won-yong Shin, MD
    • Principal Investigator: Won-young Shin, MD
  • Chuncheon, Korea, Republic of
    • Recruiting
    • Gangwon National Univ. Hospital
    • Contact: Bong-Ki Lee, MD
    • Principal Investigator: Bong-Ki Lee, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Seung-Ho Huh, MD
    • Contact: Seung-Ho Huh, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Daegu Catholic University Medical Center
    • Principal Investigator: Jin-bae Lee, MD
    • Contact: Jin-bae Lee, MD
  • Daejeon, Korea, Republic of
    • Recruiting
    • Chungnam National University Hospital
    • Contact: In-whan Seong, MD
    • Principal Investigator: In-whan Seong, MD
  • Daejeon, Korea, Republic of
    • Terminated
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gangneung, Korea, Republic of
    • Recruiting
    • Gangneung Asan Hospital
    • Contact: Sang-Sig Cheong, MD
    • Principal Investigator: Sang-Sig Cheong, MD
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Myoung-Ho Jung, MD
    • Principal Investigator: Myoung-Ho Jung, MD
  • Ilsan, Korea, Republic of
    • Recruiting
    • Inje University Ilsan Paik Hospital
    • Contact: Sung-wook Kwon, MD
    • Principal Investigator: Sung-wook Kwon, MD
  • Incheon, Korea, Republic of
    • Withdrawn
    • Gachon University Gil Hospital
  • Incheon, Korea, Republic of
    • Withdrawn
    • Inha University Hospital
  • Jeonju, Korea, Republic of
    • Recruiting
    • Presbyterian Medical Center
    • Contact: Jong-pil Park, MD
    • Principal Investigator: Jong-pil Park, MD
  • Kwangju, Korea, Republic of
    • Recruiting
    • Kwangju Christian Hospital
    • Contact: Seung-uk Lee, MD
    • Principal Investigator: Seung-uk Lee, MD
  • Pusan, Korea, Republic of
    • Recruiting
    • Dong-A Medical Center
    • Contact: Moo-Hyun Kim, MD
    • Principal Investigator: Moo-hyun Kim, MD
  • Pusan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
    • Contact: Gwang-soo Cha, MD
    • Principal Investigator: Gwang-soo Cha, MD
  • Pusan, Korea, Republic of
    • Recruiting
    • Inje University Pusan Paik Hospital
    • Contact: Tae-hyun Yang, MD
    • Principal Investigator: Tae-hyun Yang, MD
  • Seongnam, Korea, Republic of
    • Terminated
    • Bundang CHA Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Hyuck-Moon Kwon, MD
    • Principal Investigator: Hyuck-moon Kwon, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Jae-hyoung Park, MD
    • Principal Investigator: Jae-hyoung Park, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Cheol-ung Choi, MD
    • Principal Investigator: Cheol-ung Choi, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangbuk Samsung Hospital
    • Principal Investigator: Jong-young Lee, MD
    • Contact: Jong-young Lee, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangdong Sacred Heart Hospital
    • Contact: Kyoo-rok Han, MD
    • Principal Investigator: Kyoo-rok Han, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Hallym University Kangnam Sacred Heart Hospital
    • Contact: Jung-rae Cho, MD
    • Principal Investigator: Jung-rae Cho, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea Seoul St. Mary's Hospital
    • Contact: Hun-jun Park, MD
    • Principal Investigator: Hun-jun Park, MD
  • Seoul, Korea, Republic of
    • Terminated
    • The Catholic University of Korea St. Paul's Hospital
  • Suncheon, Korea, Republic of
    • Recruiting
    • St.Carollo Hospital
    • Contact: Jang-hyun Cho, MD
    • Principal Investigator: Jang-hyun Cho, MD
  • Ulsan, Korea, Republic of
    • Recruiting
    • Ulsan University Hospital
    • Contact: Sang-gon Lee, MD
    • Principal Investigator: Sang-gon Lee, MD
  • Wonju, Korea, Republic of
    • Recruiting
    • Wonju Severance Christian Hospital
    • Contact: Jang-young Kim, MD
    • Principal Investigator: Jang-young Kim, MD
  • Yangsan, Korea, Republic of
    • Recruiting
    • Pusan National University Yangsan Hospital
    • Contact: Jun-hong Kim, MD
    • Principal Investigator: Jun-hong Kim, MD
  • Republic Of Korea
    • Seoul, Republic Of Korea, Korea, Republic of
      • Recruiting
      • The Catholic University of Korea, Yeouido St. Mary's Hospital
      • Contact: Young-kyoung Sah, MD
      • Principal Investigator: Young-kyoung Sah, MD
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Recruiting
      • Asan Medical Center
      • Contact: Seung-jung Park, MD, PhD
      • Principal Investigator: Seung-jung Park, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 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, 2025
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimated): November 1, 2015

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

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: Heart Diseases; Vascular Diseases; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; 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.