A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
Public ClinicalTrials.gov record NCT01118117. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01118117
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 276 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2010 (Type not available)
- Primary completion
- Jul 2013 (Actual)
- Completion
- Apr 2016 (Actual)
- Last update posted
- Nov 20, 2017
2010 – 2016
United States locations
- U.S. sites
- 31
- U.S. states
- 18
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Alabama | Birmingham | Alabama | 35294 | — |
| Cardiology Associates of Mobile | Fairhope | Alabama | 36532 | — |
| Central Arkansas Veteran's Healthcare System | Little Rock | Arkansas | 72205 | — |
| Long Beach VA Healthcare Center | Long Beach | California | 90822 | — |
| Christiana Care | Newark | Delaware | 19718 | — |
| Bradenton Cardiology Center | Bradenton | Florida | 34205 | — |
| Florida Research Network | Gainesville | Florida | 32605 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | — |
| Coastal Vascular and Interventional, PLLC | Pensacola | Florida | 32504 | — |
| Cardiovascular Associates | Elk Grove Village | Illinois | 60007 | — |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | — |
| University of Iowa Healthcare | Iowa City | Iowa | 52242 | — |
| Kings Daughters Medical Center | Ashland | Kentucky | 41101 | — |
| Michigan Heart | Ypsilanti | Michigan | 48197 | — |
| Hunterdon Cardiovascular Associates | Flemington | New Jersey | 08822 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Hillsboro Cardiology | Hillsboro | Oregon | 97123 | — |
| Central Bucks Specialists | Doylestown | Pennsylvania | 18901 | — |
| St. Mary Medical Centere Research Institute | Langhorne | Pennsylvania | 19047 | — |
| Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania | 17043 | — |
| Berks Cardiologists, Ltd | Wyomissing | Pennsylvania | 19610 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29401 | — |
| South Carolina Heart Center | Columbia | South Carolina | 29204 | — |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | — |
| Premier Clinical Reesearch | Knoxville | Tennessee | 37909 | — |
| East Tennessee Cardiovascular Research-Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | — |
| Amarillo Heart Clinical Research Institute | Amarillo | Texas | 79106 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Centra Cardiovascular Group | Lynchburg | Virginia | 24501 | — |
| Sentara Medical Group | Norfolk | Virginia | 23507 | — |
| Columbia- St. Mary's | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01118117, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01118117 live on ClinicalTrials.gov.