Coronary Stenosis
Conditions
Keywords
BioFreedom, Drug Eluting Stent, Coronary Artery Disease
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.
Interventions
DEVICEBIOFREEDOM™ FAMILY stent
Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target- Vessel Revascularization | 5 year | — |
| Target- Lesion Revascularization | 5 year | — |
| Stent thrombosis | 5 year | — |
| Stroke | 5 year | — |
| Composite event rate of cardiac death or myocardial infarction (MI) | 5 year | — |
| All cause death | 5 year | — |
| Cardiac death | 5 year | — |
| Myocardial Infarction | 5 year | — |
| Composite event rate of death or myocardial infarction (MI) | 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. |
Countries
South Korea
Outcome results
None listed