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NCT01118117 · ClinicalTrials.gov registry record · NA
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
A NA study of Peripheral Vascular Disease, sponsored by Terumo Medical Corporation.
- Completed
- Registry status
- NA
- Development phase
- 276
- Enrollment target
- 20
- Study locations
NCT01118117 is a NA study of Peripheral Vascular Disease that has completed, run by Terumo Medical Corporation. The registered enrollment target is 276 participants, roughly in line with the 271-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target. The trial reports 20 study locations across 13 states.
The verdict
NCT01118117, a NA study of Peripheral Vascular Disease, has completed, sponsored by Terumo Medical Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 276 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as NA. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 271-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target. The listed sponsor is Terumo Medical Corporation, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT01118117 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Pennsylvania, Alabama.
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.
What interventions are being tested in trial NCT01118117?
The interventions under investigation include: Misago™ Self-Expanding Stent System (DEVICE).
Who is sponsoring clinical trial NCT01118117?
This trial is sponsored by Terumo Medical Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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