Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
NCT01118117 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Misago™ Self-Expanding Stent System
Study Locations (20)
Florida
- Bradenton Cardiology Center — Bradenton
- Florida Research Network — Gainesville
- First Coast Cardiovascular Institute — Jacksonville
- Coastal Vascular and Interventional, PLLC — Pensacola
Pennsylvania
- Central Bucks Specialists — Doylestown
- St. Mary Medical Centere Research Institute — Langhorne
- Pinnacle Health Cardiovascular Institute — Wormleysburg
Alabama
- University Of Alabama — Birmingham
- Cardiology Associates of Mobile — Fairhope
Iowa
- Midwest Cardiovascular Research Foundation — Davenport
- University of Iowa Healthcare — Iowa City
Arkansas
- Central Arkansas Veteran's Healthcare System — Little Rock
California
- Long Beach VA Healthcare Center — Long Beach
Delaware
- Christiana Care — Newark
Illinois
- Cardiovascular Associates — Elk Grove Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2010-07 |
| Est. Completion | 2016-04 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01118117
The ClinicalTrials.gov registry entry for NCT01118117 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Terumo Medical Corporation, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Peripheral Vascular Disease appearing as the primary indexed condition, and to 1 intervention — of which Misago™ Self-Expanding Stent System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01118117 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01118117 about?
NCT01118117 is a clinical study titled "A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery". 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 sa...
What is the current status of trial NCT01118117?
This trial is currently completed. It is a NA study. The enrollment target is 276 participants. The study started on 2010-07. Estimated completion is 2016-04.
What conditions does trial NCT01118117 study?
This clinical trial studies the following conditions: Peripheral Vascular Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01118117?
The interventions under investigation include: Misago™ Self-Expanding Stent System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01118117?
This trial is sponsored by Terumo Medical Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01118117 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.