Clinical trial NCT02060968: IRIS-PREMIER REGISTRY
Official title: Evaluation of Effectiveness and Safety of Promus PREMIER in Routine Clinical Practice; A Multicenter, Phase-IV, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Keywords: Promus PREMIER
Routine Clinical Practice
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Boston Scientific Korea Co. Ltd
First posted: 2014-02-12
Enrollment: 2006
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Promus PREMIER stent

Brief summary: The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in Routine Clinical Practice


Eligibility criteria: Inclusion Criteria:

* Age 20 and more
* Intervention with Promus PREMIER everolimus eluting coronary stent
* Agreed with written informed consent form

Exclusion Criteria:

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

Primary outcomes:
measure: Composite event rate
timeFrame: 1year
Secondary outcomes:
measure: All death
timeFrame: 5year
measure: Cardiac death
timeFrame: 5year
measure: Myocardial infarction
timeFrame: 5year
measure: Composite event of death or myocardial infarction
timeFrame: 5year
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5year
measure: Target Vessel revascularization
timeFrame: 5year
measure: Target lesion revascularization
timeFrame: 5year
measure: Stent thrombosis by an Academic Research Consortium (ARC) criteria
timeFrame: 5year
measure: Stroke
timeFrame: 5year
measure: Procedural success
timeFrame: 3day
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
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: 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: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Kosin University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
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: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: