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The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure. | four-months and twelve-months post-procedure | |
| NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure. | four-months and twelve-months post-procedure | |
| Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure. | four-months and twelve months post-procedure | |
| Four and twelve month target vessel failure (TVF). | Four and twelve month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. E. Sousa, MD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17621671 | Background | Nakamura M, Abizaid A, Hirohata A, Honda Y, Sousa JE, Fitzgerald PJ. Efficacy of reduced-dose sirolimus-eluting stents in the human coronary artery: serial IVUS analysis of neointimal hyperplasia and luminal dimension. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):946-51. doi: 10.1002/ccd.21272. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |