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| Name | Class |
|---|---|
| Conor Medsystems | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.
Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES |
|
| 2 | Active Comparator | TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoStar Paclitaxel Drug Eluting Coronary Stent System | Device | Drug eluting stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death | 8 months | |
| In-segment late lumen loss | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device, lesion and procedure success | At procedure or hospital discharge | |
| Incidence of MACE | 30 days, 9 months and 12 months | |
| Coronary angiography in the angiographic cohort |
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Inclusion Criteria:
General Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dean J Kereiakes, MD | The Christ Hospital, Cincinnati, Ohio | Principal Investigator |
| Mitchell W Krucoff, MD | Duke University Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States | ||
| Christ Linder |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18599890 | Result | Kereiakes DJ, Petersen JL, Batchelor WB, Fitzgerald PJ, Mehran R, Lansky A, Tsujino I, Schofer J, Dubois C, Verheye S, Cristea E, Garg J, Wijns W, Krucoff MW. Clinical and angiographic outcomes in diabetic patients following single or multivessel stenting in the COSTAR II randomized trial. J Invasive Cardiol. 2008 Jul;20(7):335-41. | |
| 18420096 |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent |
| Device |
Drug eluting stent |
|
| 9 months |
| Target lesion revascularization | 8 months |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, Fitzgerald PJ, Garg J, Turco MA, Simonton CA 3rd, Verheye S, Dubois CL, Gammon R, Batchelor WB, O'Shaughnessy CD, Hermiller JB Jr, Schofer J, Buchbinder M, Wijns W; COSTAR II Investigators Group. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J Am Coll Cardiol. 2008 Apr 22;51(16):1543-52. doi: 10.1016/j.jacc.2008.01.020. |