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The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4.0 CYPHER Sirolimus-Eluting Coronary Stent | Device | 4.0 CYPHER Sirolimus-Eluting Coronary Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA. | 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced | 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure | |
| Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauri Laura, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
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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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| 6 months post-procedure |
| In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure. | 6 months post-procedure |
| Target lesion revascularization (TLR) at 6 and 9 months post-procedure. | 6 and 9 months post-procedure |
| Target vessel revascularization (TVR) at 6 and 9 months post-procedure. | 6 and 9 months post-procedure |
| Target vessel failure (TVF) at 6 and 9 months post-procedure. | 6 and 9 months post-procedure |
| Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers. | post-procedure and six months in a subset of approximately 50 patients |
| Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. | End of study |
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. | End of Study |
| Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay. | during the hospital stay |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |