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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Include Criteria:

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

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

3. 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

Exclusion Criteria:

1. Age < 18 years

2. Life expectancy < 2 years

3. Pregnant, breast-feeding, or planning to become pregnant within 60 months

4. Inability or refusal to give informed consent by the patient or legally authorized
representative

5. Unwilling or unable to comply with the follow-up schedule, required clinical
assessments, and imaging

6. Simultaneous participation in another investigation study, unless the patient is at
least 30 days beyond the primary endpoint of any previous study

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Aortic abdominal aneurysm
  • Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
    Endovascular aneurysm repair

Recruiting Locations

University of Alabama Birmingham Hospital
Birmingham, Alabama 35294
Contact:
Adam Beck, MD

UC San Diego
La Jolla, California 92037
Contact:
Mahmoud Malas, MD

University of Southern California
Los Angeles, California 90031
Contact:
Sukgu Han, MD

Stanford Hospitals and Clinics
Stanford, California 94305
Contact:
Jason Lee, MD

Medstar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Steven Abramowitz, MD

University of Florida Shands Hospital
Gainesville, Florida 32610
Contact:
Zain Shahid, MD

Tampa General Hospital
Tampa, Florida 33606
Contact:
Dean Arnaoutakis, MD

Emory University Hospital
Atlanta, Georgia 30322
Contact:
Yazan Duwayri, MD

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Neel Mansukhani, MD

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Michael Soult, MD

Endeavor Health
Naperville, Illinois 60540
Contact:
George Pontikis, MD

Methodist Hospital of Indiana
Indianapolis, Indiana 46202
Contact:
Andres Fajardo, MD

University of Maryland
Baltimore, Maryland 21201
Contact:
Shahab Toursavadkohi, MD

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Matthew Eagleton, MD

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Marc Schermerhorn, MD

University of Massachusetts
Worcester, Massachusetts 01655
Contact:
Andres Schanzer, MD

University of Michigan Health System
Ann Arbor, Michigan 48109
Contact:
Jonathan Eliason, MD

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Randall DeMartino, MD

Barnes Jewish Hospital
Saint Louis, Missouri 63110
Contact:
John Ohman, MD

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Bjoern Suckow, MD

New York University Langone Medical Center
New York, New York 10016
Contact:
Thomas Maldonado, MD

Columbia University Irving Medical Center/NY Presbyterian Hospital
New York, New York 10032

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Federico Parodi, MD

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Francis Caputo, MD

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Grace Wang, MD

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Ravi Veeraswamy, MD

Holston Valley Hospital
Kingsport, Tennessee 37660
Contact:
Robert "Bo" Allen, MD

Ut Southwestern
Dallas, Texas 75235
Contact:
Carlos Timaran, MD

Memorial Hermann Texas Medical Center/UT Health
Houston, Texas 77030
Contact:
Naveed Saqib, MD

Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24014

More Details

NCT ID
NCT04875429
Status
Recruiting
Sponsor
Cook Research Incorporated

Study Contact

Chanda Bell, RN, BSN
765-463-7537
chanda.bell@cookmedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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