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The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.
This is a multicenter (55 sites), prospective, 2-arm randomized, double-blind study designed to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent as compared to the uncoated Bx VELOCITYTM stent. A total of 1100 patients will be entered in the study and will be randomized on a 1:1 basis. Patients with de novo native coronary artery lesions >/=15mm and </=30mm in length and >/=2.50mm to \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cypher Bx Velocity |
|
| 2 | Active Comparator | Uncoated Bx Velocity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYPHER Sirolimus-Eluting Stent | Device | CYPHER Sirolimus-Eluting Stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure. | 9 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target vessel revascularization at 30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure; | 30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure | |
| Angiographic binary restenosis (>/=50% diameter stenosis) 8 mo post-procedure; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin B. Leon, MD | New York Presbyterian Hospital/Columbia University Medical Center | Principal Investigator |
| Jeffrey Moses, MD | New York Presbyterian Hospital/Columbia University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital/Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14523139 | Background | Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071. | |
| 19389558 |
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| Uncoated BX VELOCITY Balloon-Expandable Stent |
| Device |
Uncoated BX VELOCITY Balloon-Expandable Stent |
|
| 8 months post-procedure |
| In-stent and in-lesion MLD at 8 mo post-procedure; | 8 months post-procedure |
| Target lesion revascularization at 9 mo post-procedure; | 9 months post-procedure |
| Target vessel revascularization at 9 mo post-procedure; | 9 months 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; | Study Completion |
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method; | Study Completion |
| 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 |
| Costs associated with the index hospitalization and length of stay, and repeat hospitalizations during the 12-month post-procedure follow-up period. | 12-month post-procedure |
| Weisz G, Leon MB, Holmes DR Jr, Kereiakes DJ, Popma JJ, Teirstein PS, Cohen SA, Wang H, Cutlip DE, Moses JW. Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial. J Am Coll Cardiol. 2009 Apr 28;53(17):1488-97. doi: 10.1016/j.jacc.2009.01.050. |
| 19327417 | Result | Popma JJ, Tiroch K, Almonacid A, Cohen S, Kandzari DE, Leon MB. A qualitative and quantitative angiographic analysis of stent fracture late following sirolimus-eluting stent implantation. Am J Cardiol. 2009 Apr 1;103(7):923-9. doi: 10.1016/j.amjcard.2008.12.022. |
| 19539252 | Result | Chacko R, Mulhearn M, Novack V, Novack L, Mauri L, Cohen SA, Moses J, Leon MB, Cutlip DE. Impact of target lesion and nontarget lesion cardiac events on 5-year clinical outcomes after sirolimus-eluting or bare-metal stenting. JACC Cardiovasc Interv. 2009 Jun;2(6):498-503. doi: 10.1016/j.jcin.2009.03.013. |
| 17296825 | Derived | Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. doi: 10.1056/NEJMoa066633. Epub 2007 Feb 12. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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