Zenith® Fenestrated+ Endovascular Graft Clinical Study

Status: Recruiting
Location: See all (30) 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
RECRUITING
Birmingham
California
UC San Diego
RECRUITING
La Jolla
University of Southern California
RECRUITING
Los Angeles
Stanford Hospitals and Clinics
RECRUITING
Stanford
Washington, D.c.
Medstar Washington Hospital Center
RECRUITING
Washington
Florida
University of Florida Shands Hospital
RECRUITING
Gainesville
Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory University Hospital
RECRUITING
Atlanta
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Loyola University Medical Center
RECRUITING
Maywood
Endeavor Health
RECRUITING
Naperville
Indiana
Methodist Hospital of Indiana
RECRUITING
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
University of Massachusetts
RECRUITING
Worcester
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Barnes Jewish Hospital
RECRUITING
Saint Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
New York
Columbia University Irving Medical Center/NY Presbyterian Hospital
RECRUITING
New York
New York University Langone Medical Center
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Holston Valley Hospital
NOT_YET_RECRUITING
Kingsport
Texas
Ut Southwestern
RECRUITING
Dallas
Memorial Hermann Texas Medical Center/UT Health
RECRUITING
Houston
Virginia
Carilion Roanoke Memorial Hospital
RECRUITING
Roanoke
Contact Information
Primary
Chanda Bell, RN, BSN
chanda.bell@cookmedical.com
765-463-7537
Backup
Maja Mollegaard Christensen
maja.christensen@cookmedical.com
+45 56868797
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2031-04
Participants
Target number of participants: 102
Treatments
Experimental: Aortic abdominal aneurysm
Sponsors
Leads: Cook Research Incorporated

This content was sourced from clinicaltrials.gov