IRIS-Onyx Cohort in the IRIS-DES Registry

Sponsor

Seung-Jung Park (Other)

Overall Status

Recruiting

CT.gov ID

NCT02593994

Collaborator

CardioVascular Research Foundation, Korea (Other), Medtronic Korea Co., Ltd. (Other)

4,000

Enrollment

Locations

132

Anticipated Duration (Months)

121.2

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Arterial Occlusive Diseases Cardiovascular Diseases Percutaneous Transluminal Angioplasty	Device: Onyx Drug Eluting Stent group

Study Design

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Onyx Drug Eluting Stent	Device: Onyx Drug Eluting Stent group

Arm

Intervention/Treatment

Onyx Drug Eluting Stent

Device: Onyx Drug Eluting Stent group

Outcome Measures

Primary Outcome Measures

Stent thrombosis [1 year]
As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis

Secondary Outcome Measures

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]
Composite event rate [5 year]
death, myocardial infarction, target vessel revascularization
Target Vessel revascularization [5 year]
Target Lesion revascularization [5 year]
Stent thrombosis [5 year]
Stroke [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul	Republic Of Korea	Korea, Republic of
2	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736
3	Hallym University Sacred Heart Hospital	Anyang		Korea, Republic of
4	Soon Chun Hyang University Hospital Bucheon	Bucheon		Korea, Republic of
5	Soon Chun Hyang University Hospital Cheonan	Cheonan		Korea, Republic of
6	Gangwon National Univ. Hospital	Chuncheon		Korea, Republic of
7	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
8	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
9	Chungnam National University Hospital	Daejeon		Korea, Republic of
10	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
11	Gangneung Asan Hospital	Gangneung		Korea, Republic of
12	Chonnam National University Hospital	Gwangju		Korea, Republic of
13	Inje University Ilsan Paik Hospital	Ilsan		Korea, Republic of
14	Gachon University Gil Hospital	Incheon		Korea, Republic of
15	Inha University Hospital	Incheon		Korea, Republic of
16	Presbyterian Medical Center	Jeonju		Korea, Republic of
17	Kwangju Christian Hospital	Kwangju		Korea, Republic of
18	Dong-A Medical Center	Pusan		Korea, Republic of
19	Inje University Pusan Paik Hospital	Pusan		Korea, Republic of
20	Pusan National University Hospital	Pusan		Korea, Republic of
21	Gangnam Severance Hospital	Seoul		Korea, Republic of
22	Hallym University Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of
23	Kangbuk Samsung Hospital	Seoul		Korea, Republic of
24	Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of
25	Korea University Anam Hospital	Seoul		Korea, Republic of
26	Korea University Guro Hospital	Seoul		Korea, Republic of
27	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of
28	The Catholic University of Korea St. Paul's Hospital	Seoul		Korea, Republic of
29	St.carollo Hospital	Suncheon		Korea, Republic of
30	Bundang CHA Hospital	Sungnam		Korea, Republic of
31	Ulsan University Hospital	Ulsan		Korea, Republic of
32	Wonju Severance Christian Hospital	Wonju		Korea, Republic of
33	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of