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OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a SFA stent procedure using the Misago™ Peripheral Self Expanding stent once all of the inclusion and none of the exclusion criteria are met. The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days, 6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY study after he/she signs the informed consent and meets all inclusion/exclusion criteria.
The study objectives are to demonstrate that efficacy and safety of this novel stent design are not inferior to historical PTA and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical trial of the MisagoTM self expanding stent for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Peripheral Vascular Disease
Misago™ Self-Expanding Stent System
Central Bucks Specialists
Terumo Medical Corporation
Published on BioPortfolio: 2014-08-27T03:13:54-0400
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