Clinical Trials Logo
  1. Home
  2. Peripheral Vascular Disease
  3. NCT01118117

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

Peripheral Vascular Disease Clinical Trial

Official title:
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Clinical Trial Summary

OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (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 Percutaneous Transluminal Angioplasty (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 Misago™ Self-Expanding Stent System for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01118117
Study type Interventional
Source Terumo Medical Corporation
Contact
Status Completed
Phase N/A
Start date July 2010
Completion date April 2016
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05335525 - Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02271529 - Zilver PTX Delivery System N/A
Completed NCT02228564 - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Recruiting NCT02054871 - RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Completed NCT00574782 - Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) N/A
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Completed NCT01355406 - Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System N/A
Recruiting NCT05804097 - Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? Phase 4
Recruiting NCT03638115 - The VaSecure BTK Study N/A
Active, not recruiting NCT03241459 - Safety and Efficacy of the SurVeil™ Drug-Coated Balloon N/A
Active, not recruiting NCT01661231 - Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe N/A
Completed NCT01722877 - JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions N/A
Completed NCT01444378 - Absolute Pro® MOMENTUM™ N/A
Completed NCT00753337 - The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study N/A
Completed NCT00538226 - Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg Phase 1
Completed NCT00593385 - Atrium iCAST Iliac Stent Pivotal Study N/A
Recruiting NCT00385385 - RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease Phase 2
Completed NCT00392509 - ALD-301 for Critical Limb Ischemia, Randomized Trial Phase 1/Phase 2