Clinical trial NCT03190057: IRIS-BioFreedom Cohort in the IRIS-DES Registry
Official title: Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Stenosis
Keywords: BioFreedom
Drug Eluting Stent
Coronary Artery Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2017-06-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with BIOFREEDOM™ FAMILY stent

Brief summary: The objective of this study is to evaluate effectiveness and safety of BIOFREEDOM™ FAMILY stent in the "real world" daily practice as compared with other drug-eluting stents.

Detailed description: BIOFREEDOM™ FAMILY stent means that Biofreedom stent, Biofreedom Ultra and the other stents with names starting with Biofreedom.

Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Patient with BIOFREEDOM™ FAMILY stent
* Written consent

Exclusion Criteria:

* Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time
* Life-expectancy less than 1 year
* Cardiac shock

Primary outcomes:
measure: Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
timeFrame: 1 year
Secondary outcomes:
measure: All cause death
timeFrame: 5 year
measure: Cardiac death
timeFrame: 5 year
measure: Myocardial Infarction
timeFrame: 5 year
measure: Composite event rate of death or myocardial infarction (MI)
timeFrame: 5 year
measure: Composite event rate of cardiac death or myocardial infarction (MI)
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 rate
timeFrame: 5 day
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang 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: 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: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA 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: The Catholic Univ. of Korea Seoul St. Mary's hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: