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The main objective of this study is to assess in-stent late lumen loss in diabetic patients with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as compared to the Bx VELOCITY balloon-expandable stent.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus-Eluting BX Velocity Balloon-Expandable Stent | Device |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late lumen loss as measured by QCA at six months post-procedure. In-stent measurement is defined as the measurement within the stented segment. | 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 and 1 year post-procedure | at 30 days, 6 months and 1 year post-procedure | |
| Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months and 1 year post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Buchbinder, MD | Scripps Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Cardiovascular Medicine | La Jolla | California | 92037 | United States | ||
| Florida Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18949772 | Result | Chan C, Zambahari R, Kaul U, Lau CP, Whitworth H, Cohen S, Buchbinder M; DECODE Investigators. A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: the DECODE study. Catheter Cardiovasc Interv. 2008 Nov 1;72(5):591-600. doi: 10.1002/ccd.21719. |
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| at 30 days, 6 months and 1 year post-procedure |
| Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months and 1 year post-procedure | at 30 days, 6 months and 1 year 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 | Throughout study |
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method | Throughout 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 | Throughout study |
| In-stent mean percent diameter stenosis (%DS), Binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months | at post-procedure and at 6-months |
| In-lesion mean percent diameter stenosis (%DS), mean lumen diameter (MLD), binary restenosis and late lumen loss as measured by quantitative coronary angiography at post-procedure and at 6-months | at post-procedure and at 6-months |
| Glycemic control as measured by HbA1C at 6 months and 1 year follow-up | at 6 months and 1 year follow-up |
| Orlando |
| Florida |
| 32803 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| St Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Queen Mary Hospital | Hong Kong | China |
| Batra Hospital & Research Centre | New Delhi | National Capital Territory of Delhi | 110062 | India |
| Apollo Hospital | Chennai | Tamil Nadu | 600006 | India |
| Jaslok Hospital & Research Centre | Mumbai | 400 026 | India |
| Escorts Heart Institute & Research Centre | New Delhi | 110 025 | India |
| National Heart Institute | Kuala Lumpur | 50400 | Malaysia |
| National Heart Center | Singapore | 168752 | Singapore |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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