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

NCT01118117•Terumo Medical Corporation

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Pre-procedure:
•1. Female or male age greater than or equal to 18 years and of legal consent.
•2. Subjects must be willing to comply with the specified follow-up evaluation schedule.
•3. Informed consent (signed and dated) prior to any study-related evaluation or procedures.
•4. Symptomatic leg ischemia without tissue loss by Rutherford classification (category 2, 3 or 4).
•5. Resting ABI of \<0.9, or abnormal exercise ABI.
•6. De novo lesion(s) (one or multiple lesions) with \>50% stenosis, or occlusion which require treatment, and a total lesion length of \>40 mm and \<150 mm of the above-the-knee SFA in one limb. The target lesion should be treatable with no more than two overlapping stents, minimizing the stent overlap up to 10 mm (by visual estimate).
•7. All lesions are at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and at least 2 cm distal to the origin of the profunda artery.
•8. Reference vessel diameter of \>4.0 mm and \<7.0 mm.
•9. Target lesion length of \> 40 mm and \<150 mm.
+1 more criteria

Exclusion Criteria

•1. Pre-existing autoimmune disease.
•2. Pre-existing terminal illness with life expectancy of less than three (3) years.
•3. Participation in another investigational device or therapeutic intervention trial within the past three (3) months.
•4. Previous enrollment in this study.
•5. Previous bypass surgery or stenting in the SFA or distally.
•6. Scheduled for a staged procedure to treat lesions within the aorta or run-off after enrollment.
•7. Co-existing aneurysmal disease of the aorta, iliac artery, SFA, or popliteal arteries requiring treatment.
•8. Any inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion) that has not been treated prior to enrollment (Treatment of iliac arteries before SFA intervention is permitted, except for common femoral stenosis).
•9. A recent (\< 6 week) history of clinically significant gastrointestinal bleeding, major surgery, myocardial infarction or untreated coagulopathy.
•10. Known sensitivity or allergy to aspirin, radiographic contrast agents (that cannot be pre-treated adequately), nitinol, gold, or both heparin and bivalirudin.
+13 more criteria

Locations (31)

University Of Alabama

Birmingham, Alabama, United States

Cardiology Associates of Mobile

Fairhope, Alabama, United States

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, United States

Long Beach VA Healthcare Center

Long Beach, California, United States

Christiana Care

Newark, Delaware, United States

Bradenton Cardiology Center

Bradenton, Florida, United States

Florida Research Network

Gainesville, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Coastal Vascular and Interventional, PLLC

Pensacola, Florida, United States

Cardiovascular Associates

Elk Grove Village, Illinois, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

July 1, 2013

Completion Date

April 1, 2016

Last Updated

November 20, 2017

Enrollment

276

ACTUAL participants

Conditions

Peripheral Vascular Disease

Interventions

Misago™ Self-Expanding Stent System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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