MedTrace Logo

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

NCT01118117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2017-11-20

Study results available
· View outcomes & findings →

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

  • Peripheral Vascular Disease

Interventions

DEVICE

Misago™ Self-Expanding Stent System

Transcatheter placement of an intravascular stent(s)

Sponsors & Collaborators

  • ClinLogix. LLC

    collaborator INDUSTRY

  • Massachusetts General Hospital

    collaborator OTHER

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Terumo Medical Corporation

    lead INDUSTRY

Principal Investigators

  • John F Angle, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-07-31
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01118117 on ClinicalTrials.gov