Clinical trial NCT02720419: IRIS-Synergy Cohort in the IRIS-DES Registry
Official title: Evaluation of Effectiveness and Safety of Synergy™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: drug eluting stent
percutaneous coronary intervention
real world
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-03-25
Enrollment: 3000
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 Synergy stent

Brief summary: The purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Intervention with Synergy stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with Synergy stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock

Primary outcomes:
measure: Composite event
timeFrame: 1 year
Secondary outcomes:
measure: All death
timeFrame: 5 years
measure: Cardiac death
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Composite event of death or myocardial infarction
timeFrame: 5 years
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5 years
measure: Target vessel revascularization
timeFrame: 5 years
measure: Target lesion revascularization
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Stroke
timeFrame: 5 years
measure: Procedural success
timeFrame: 3 days
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Busan
country: Korea, Republic of
facility: Haeundae paik hospital, inje university
city: Busan
country: Korea, Republic of
facility: Inje university Pusan Paik hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart 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: Daegu
country: Korea, Republic of
facility: Yeungnam University 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: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital, The Catholic University of Korea
city: Jeju
country: Korea, Republic of
facility: Cheju Halla General Hopsital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seongnam
country: Korea, Republic of
facility: Seoul university Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji general hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung-Hee University 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: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
References: