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The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in diameter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENDEAVOR | Experimental | Drug Eluting Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Artery Stenting | Device | Drug eluting stent |
| |
| Endeavor |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Success (device, lesion, and procedure) | 9 months | |
| Major adverse cardiac event (MACE) rate | 30 days, 6, 9 and 12 months | |
| Target site revascularization (TSR), target vessel revascularization (TVR), and target vessel failure (TVF) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin B Leon, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Rosa Memorial Hospital | Santa Rosa | California | 95405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21232717 | Derived | Mauri L, Massaro JM, Jiang S, Meredith I, Wijns W, Fajadet J, Kandzari DE, Leon MB, Cutlip DE, Thompson KP. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc Interv. 2010 Dec;3(12):1240-9. doi: 10.1016/j.jcin.2010.08.021. |
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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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| Device |
Drug eluting stent |
|
| 9 months |
| For patients receiving overlapping stents at the target lesion: angiographic parameters (in-stent and in-segment), including: late lumen loss | 8 months |
| Late loss index | 9 months |
| Angiographic binary restenosis (ABR) rate | 9 months |
| Minimum luminal diameter (MLD) | 9 months |
| Percent diameter stenosis (%DS) | 9 months |
| Neointimal hyperplastic volume as measured by intravascular ultrasound (IVUS) | 8 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |