Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
| Registry | NCT03190057, acronym IRISBioFreedom |
|---|---|
| Status | Terminated - Funding issue |
| Study type | Observational |
| Enrollment | 218 (Actual) |
| Sponsor | Seung-Jung Park (Other); collaborators: CardioVascular Research Foundation, Korea |
| Conditions | Coronary Stenosis |
| Interventions | BIOFREEDOM™ FAMILY stent (Device) |
| Dates | start 2019-05-20, primary completion 2025-09-29, completion 2025-09-29, first posted 2017-06-16, last updated 2025-09-30 |
| Locations | 8 sites in South Korea |
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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.
BIOFREEDOM™ FAMILY stent means that Biofreedom stent, Biofreedom Ultra and the other stents with names starting with Biofreedom.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Consecutive percutaneous coronary intervention | Device: BIOFREEDOM™ FAMILY stent |
Sex: All, ages: 19 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea | |
| Soonchunhyang University Hospital, Cheonan | Cheonan | South Korea | |
| The Catholic University of Korea, Daejeon ST. Mary's Hospital | Daejeon | South Korea | |
| Chonnam National University Hospital | Gwangju | South Korea | |
| Gachon University Gil Hospital | Incheon | South Korea | |
| Inje University Pusan Paik Hospital | Pusan | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Eulji General Hospital | Seoul | South Korea |