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A Multi-center Clinical Trial of the Misago(TM) Self-Expanding Stent System for Superficial Femoral Artery

2014-08-27 03:13:54 | BioPortfolio

Summary

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.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Peripheral Vascular Disease

Intervention

Misago™ Self-Expanding Stent System

Location

Central Bucks Specialists
Doylestown
Pennsylvania
United States
18901

Status

Recruiting

Source

Terumo Medical Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:54-0400

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