IRIS-BioFreedom Cohort in the IRIS-DES Registry
- Conditions
- Coronary Stenosis
- Interventions
- Device: BIOFREEDOM™ FAMILY stent
- Registration Number
- NCT03190057
- Lead Sponsor
- Seung-Jung Park
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Age 19 and more
- Patient with BIOFREEDOM™ FAMILY stent
- Written consent
- Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time
- Life-expectancy less than 1 year
- Cardiac shock
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Consecutive percutaneous coronary intervention BIOFREEDOM™ FAMILY stent -
- Primary Outcome Measures
Name Time Method Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) 1 year
- Secondary Outcome Measures
Name Time Method All cause death 5 year Cardiac death 5 year Myocardial Infarction 5 year Composite event rate of death or myocardial infarction (MI) 5 year Composite event rate of cardiac death or myocardial infarction (MI) 5 year Target- Vessel Revascularization 5 year Target- Lesion Revascularization 5 year Stent thrombosis 5 year Stroke 5 year Procedural Success rate 5 day defined as achievement of a final diameter stenosis of \<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.
Trial Locations
- Locations (17)
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Soonchunhyang University Hospital, Cheonan
🇰🇷Cheonan, Korea, Republic of
Gangwon National Univ. Hospital
🇰🇷Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Bundang CHA Hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of