A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Who is this study for? Adult patients with Abdominal Aortic Aneurysm
What treatments are being studied? Treovance Stent-Graft
Status: Active, not recruiting
Location: See all (32) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: No
View:

• Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement

• Subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months

Locations
United States
Alabama
University of Alabama-Birmingham
Birmingham
Arizona
Arizona Heart Institute
Phoenix
Connecticut
Danbury Hospital
Danbury
Florida
Lynn Heart and Vascular Institute
Boca Raton
Coastal Vascular and Interventional
Pensacola
Georgia
Northside Hospital Heart & Vascular Institute
Atlanta
Iowa
University of Iowa Hospital and Clinic
Iowa City
Illinois
University of Chicago
Chicago
Affiliated Surgeons of Rockford Memorial Hospital
Rockford
Massachusetts
Massachusetts General Hospital
Boston
Tufts University Medical Center
Boston
University of Massachusetts
Worcester
Michigan
Spectrum Health System
Grand Rapids
Minnesota
Mayo Clinic
Rochester
North Carolina
Mission Hospital
Asheville
Sanger Heart and Vascular Institute
Charlotte
East Carolina University / Pitt County Memorial Hospital
Greenville
New York
Albany Medical Center
Albany
Buffalo General Medical Center
Buffalo
Mount Sinai Medical Center
New York
University of Rochester -- Strong Memorial Hospital
Rochester
Stony Brook Medical Center
Stony Brook
Ohio
Cleveland Clinic Foundation
Cleveland
The Ohio State University
Columbus
Pennsylvania
Temple University School of Medicine
Philadelphia
University of Pennsylvania
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
York Hospital
York
Rhode Island
Rhode Island Hospital
Providence
South Dakota
Avera Heart Hospital
Sioux Falls
Sanford University of South Dakota Medical Center
Sioux Falls
Virginia
Sentara Vascular Specialists
Norfolk
Time Frame
Start Date: November 23, 2013
Estimated Completion Date: June 2025
Participants
Target number of participants: 150
Treatments
Experimental: Treovance
Subjects who receive the Treovance stent-graft
Authors
Sponsors
Leads: Bolton Medical

This content was sourced from clinicaltrials.gov

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