Clinical trial NCT02039739: Orsiro™ Drug Eluting Stent in Routine Clinical Practice
Official title: Evaluation of Effectiveness and Safety of Orsiro™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease
Keywords: Orsiro
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: Biotronik Korea Co., Ltd
First posted: 2014-01-20
Enrollment: 1007
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 Orsiro™ Drug Eluting Stent

Brief summary: The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice


Eligibility criteria: Inclusion Criteria:

* Age 20 and more
* Intervention with Orsiro™ Drug Eluting Stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with Orsiro™ drug 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
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: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
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: 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: Gachon University Gil Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References: