| | Jon R. Resar, M.D. |
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| | Kathleen M. Citro, R.N. |
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| | 410-955-7377 |
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| | kcitro@jhmi.edu |
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| | Spirit IV Clinical Trial |
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| | A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects with de novo Native Coronary Artery Lesions |
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| | WIRB 20060386 |
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| | Advanced Cardiovascular Systems, Inc |
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| | To evaluate the safety and effectiveness of the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of up to three native coronary artery lesions, in patients who are referred for cardiac catherterization and possible coronary stenting. Patients will be randomized to receive either the investigational XIENCE V stent or the commercially available Taxus Express Paclitaxel-Eluting stent. |
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| | Blockage in a coronary artery which has not previously been treated with a stent. |
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| | The blockage has previously been treated with a stent, or is located in a coronary artery bypass graft. There are several exclusions which can only be evaluated at the time of the cardiac catheterization. |
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| | The Johns Hopkins Hospital 600 N. Wolfe Street Baltimore, MD 21287 |
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| | No |
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| | 2/2007 |
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| | 12/2008 |