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Clinical Trial: SPIRIT II - A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System in the Treatment of Patients with De Novo Native Coronary Artery Lesions
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(Cardiovascular Therapeutics) |
CT00369
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| Sponsoring Company: |
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Guidant Corporation (Abbott Vascular Devices) |
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| Product: |
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XIENCETM V Everolimus-Eluting Coronary Stent System
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| Objective: |
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To demonstrate the safety and efficacy of the XIENCE V stent system compared to the TAXUS Express2 stent system for the treatment of CAD.
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| Inclusion Criteria: |
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Native de novo lesions
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RVD between 2.25 mm and 4.25 mm by visual estimate
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Target lesion(s) must be in a major artery or branch with a stenosis estimated visually to be ≥50% and <100% with TIMI flow ≥1
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| Exclusion Criteria: |
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Target lesion(s) located in a major epicardial vessel or a side branch previously treated with any type of PCI < 9 months prior to index procedure
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Restenosis in target lesion
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Target lesion located in a major vessel previously treated with brachytherapy
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Visible thrombus in target vessel
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Patient has a high probability that an additional procedure other than dilation and stenting will be required in the target vessel at the time of the index procedure
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| Primary Endpoints: |
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In-stent LLL at 180 days
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| PI: |
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Serruys, Patrick W., MD, PhD |
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| PI Study Site: |
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Thoraxcenter, Rotterdam, The Netherlands |
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| Trial Design: |
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| Conclusion: |
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Trial is ongoing and as of November 2005 is enrolling patients
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Last Update: December 6, 2007 |
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