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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: Completed NA study of Peripheral Vascular Disease, sponsored by Terumo Medical Corporation.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio \< 2.0 from DUS obtained within the 12 months visit window.

Conditions Studied

Peripheral Vascular Disease

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

FieldValue
Enrollment Target 276 participants
Start Date 2010-07
Est. Completion 2016-04
Phase NA
Terumo Medical Corporation

5 total trials

What the finished NCT01118117 record still lists

NCT01118117 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 271-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target.

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 names 20 study sites across 13 states, led by 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.

Learn More About Clinical Trials

Similar trials for Peripheral Vascular Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01118117's enrollment target sits among peer trials

276 7th of 25 higher than 19 of 25 other Peripheral Vascular Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Peripheral Vascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01118117, the US trial registry maintained by the National Library of Medicine. NCT01118117 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.