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The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITYâ„¢ stents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Single-dose Sirolimus-Eluting Coronary stent |
|
| 2 | Active Comparator | Double-dose Sirolimus-Eluting Coronary stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYPHER Sirolimus-Eluting Coronary Stent | Device | Single dose Sirolimus-Eluting coronary stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure. | 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, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure | |
| Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose E. Sousa, MD | Institute Dante Pazzanese of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute Dante Pazzanese of Cardiology | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19755304 | Result | Costa RA, Sousa JE, Abizaid A, Chaves A, Feres F, Sousa AG, Musumeci G, Mehran R, Fitzgerald PJ, Lansky AJ, Leon MB, Shiran A, Halon DA, Lewis BS, Guagliumi G. The randomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions. EuroIntervention. 2006 Nov;2(3):295-301. | |
| 18688066 |
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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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| CYPHER Sirolimus-Eluting Coronary Stent | Device | Double-dose Sirolimus-Eluting coronary stent |
|
|
| 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure |
| Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure |
| 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. | During Index Procedure |
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. | During Index Procedure |
| 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 |
| In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years. | 6 months and 2 years |
| In-stent and in-lesion mean percent diameter stenosis (%DS) and minimal lumen. diameter (MLD) measured by QCA post-procedure and at 6 months and 2 years. | post-procedure and at 6 months and 2 years |
| In-lesion late lumen loss measured by QCA at 6 months and 2 years. | 6 months and 2 years |
| Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years. | post-procedure 6 months and 2 years. |
| Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months. | baseline, 6, 12, and 24 months |
| C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes. | baseline, 6, 12, and 24 months |
| Hur SH, Ako J, Shimada Y, Tsujino I, Hassan AH, Abizaid A, Shiran A, Lewis BS, Guagliumi G, Cohen SA, Honda Y, Fitzgerald PJ, Sousa JE. Two-year intravascular ultrasound observations in diabetic patients treated with single and double dose sirolimus-eluting stents: results of the double dose diabetes (3D) study. J Invasive Cardiol. 2008 Aug;20(8):411-6. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |