Clinical trial NCT02593994: IRIS-Onyx Cohort in the IRIS-DES Registry
Official title: Evaluation of Effectiveness and Safety of Resolute Onyx™ and Onyx Frontier™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Percutaneous Transluminal Angioplasty
Keywords: Onyx
drug eluting stent
Routine Clinical Practice
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Medtronic Korea Co., Ltd.
First posted: 2015-11-01
Enrollment: 4500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Onyx Drug Eluting Stent

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stent thrombosis
timeFrame: 1 year
Secondary outcomes:
measure: All death
timeFrame: 5 year
measure: Cardiac death
timeFrame: 5 year
measure: Myocardial infarction
timeFrame: 5 year
measure: Composite event of death or myocardial infarction
timeFrame: 5 year
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5 year
measure: Composite event rate
timeFrame: 5 year
measure: Target Vessel revascularization
timeFrame: 5 year
measure: Target Lesion revascularization
timeFrame: 5 year
measure: Stent thrombosis
timeFrame: 5 year
measure: Stroke
timeFrame: 5 year
measure: Procedural success
timeFrame: 3 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
state: Republic Of Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Paul's Hospital
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: