Zenith® Fenestrated+ Endovascular Graft Clinical Study

Status: Active_not_recruiting
Location: See all (32) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Include Criteria:

• Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females

• Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months

• Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator

Locations
United States
Alabama
University of Alabama Birmingham Hospital
Birmingham
California
UC San Diego
La Jolla
University of Southern California
Los Angeles
Stanford Hospitals and Clinics
Stanford
Washington, D.c.
Medstar Washington Hospital Center
Washington D.c.
Florida
University of Florida Shands Hospital
Gainesville
Tampa General Hospital
Tampa
Georgia
Emory University Hospital
Atlanta
Illinois
Northwestern Memorial Hospital
Chicago
Loyola University Medical Center
Maywood
Edwards Hospital
Naperville
Indiana
Methodist Hospital of Indiana
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts General Hospital
Boston
University of Massachusetts
Worcester
Maryland
University of Maryland
Baltimore
Michigan
University of Michigan Health System
Ann Arbor
Minnesota
Mayo Clinic
Rochester
Missouri
Barnes Jewish Hospital
St Louis
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New York
Columbia University Irving Medical Center/NY Presbyterian Hospital
New York
New York University Langone Medical Center
New York
Ohio
Cleveland Clinic Foundation
Cleveland
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Holston Valley Hospital
Kingsport
Texas
Ut Southwestern
Dallas
Memorial Hermann Texas Medical Center/UT Health
Houston
Virginia
Carilion Roanoke Memorial Hospital
Roanoke
Other Locations
United Kingdom
St Thomas' Hospital
London
Time Frame
Start Date: 2023-12-08
Completion Date: 2031-08
Participants
Target number of participants: 102
Treatments
Experimental: Aortic abdominal aneurysm
Sponsors
Leads: Cook Research Incorporated

This content was sourced from clinicaltrials.gov