Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.

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

• Willing and able to comply with all study procedures and visits.

• Written informed consent to participate in the study.

• Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System.

• Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively.

Locations
United States
Arizona
Banner University Medical Center
Not yet recruiting
Phoenix
Pima Heart and Vascular
Not yet recruiting
Tucson
California
University of California, San Diego
Not yet recruiting
La Jolla
Long Beach Memorial Hospital
Not yet recruiting
Long Beach
VA San Diego
Not yet recruiting
San Diego
Colorado
University of Colorado Anschutz
Not yet recruiting
Aurora
Connecticut
Yale University
Not yet recruiting
New Haven
Washington, D.c.
Medstar Washington Hospital Center
Not yet recruiting
Washington
Florida
Boca Raton Regional Hospital
Not yet recruiting
Boca Raton
University of Florida
Not yet recruiting
Gainesville
Mount Sinai Medical Center
Not yet recruiting
Miami
Coastal Vascular and Interventional
Recruiting
Pensacola
University of South Florida / Tampa General Hospital
Not yet recruiting
Tampa
Georgia
Piedmont Heart Institute
Not yet recruiting
Atlanta
Iowa
University of Iowa Hospital and Clinic
Not yet recruiting
Iowa City
Massachusetts
Tufts Medical Center
Not yet recruiting
Boston
Michigan
McLaren Bay Region
Recruiting
Bay City
Henry Ford Hospital
Not yet recruiting
Detroit
Minnesota
Minneapolis Heart Institute / Abbott Northwestern Hospital
Not yet recruiting
Minneapolis
Missouri
Barnes Jewish Hospital at Washington University
Not yet recruiting
Saint Louis
North Carolina
Mission Health
Not yet recruiting
Asheville
East Carolina University
Not yet recruiting
Greenville
UNC Rex Hospital
Not yet recruiting
Raleigh
New Jersey
Rutgers Robert Wood Johnson Medical Center
Not yet recruiting
New Brunswick
New York
Montefiore Medical Center
Not yet recruiting
Bronx
Sisters of Charity Hospital, Catholic Health System
Not yet recruiting
Buffalo
Lenox Hill Hospital / Northwell Health
Not yet recruiting
New York
The Mount Sinai Hospital
Not yet recruiting
New York
University of Rochester -- Strong Memorial Hospital
Not yet recruiting
Rochester
Stony Brook Medical Center
Not yet recruiting
Stony Brook
Oklahoma
Oklahoma University Health and VA Medical Center
Not yet recruiting
Oklahoma City
Oregon
Oregon Health and Sciences University
Not yet recruiting
Portland
Pennsylvania
University of Pittsburg Medical Center
Not yet recruiting
Pittsburgh
South Dakota
Sanford University of South Dakota Medical Center
Not yet recruiting
Sioux Falls
Texas
Cardiothoracic and Vascular Surgeons
Recruiting
Austin
Methodist Hospital
Not yet recruiting
Houston
Utah
University of Utah Hospital
Not yet recruiting
Salt Lake City
Virginia
Sentara Heart Hospital
Not yet recruiting
Norfolk
Virginia Commonwealth University
Not yet recruiting
Richmond
Wisconsin
Medical College of Wisconsin
Not yet recruiting
Milwaukee
Contact Information
Primary
Gretchen Wild
g.wild@terumoaortic.com
954-779-6393
Time Frame
Start Date: January 20, 2021
Estimated Completion Date: July 31, 2027
Participants
Target number of participants: 300
Treatments
Experimental: Subjects who receive the TREO Abdominal Stent-Graft System
Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System.
Sponsors
Leads: Bolton Medical

This content was sourced from clinicaltrials.gov

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