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Funding issue
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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consecutive percutaneous coronary intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOFREEDOM™ FAMILY stent | Device | Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All cause death | 5 year | |
| Cardiac death | 5 year | |
| Myocardial Infarction |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with BIOFREEDOM™ FAMILY stent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea | ||||
| Soonchunhyang University Hospital, Cheonan |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 | 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. | 5 day |
| 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 |
| D014652 |
| Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |