Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04875429

Zenith® Fenestrated+ Clinical Study

Led by Cook Research Incorporated · Updated on 2026-03-23

105

Participants Needed

33

Research Sites

412 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. Up to 60 additional subjects may be enrolled in Continued Access phase of the study

CONDITIONS

Official Title

Zenith® Fenestrated+ Clinical Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 greater than twice the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Life expectancy less than 2 years
  • Pregnant, breast-feeding, or planning to become pregnant within 60 months
  • Inability or refusal to give informed consent
  • Unwilling or unable to comply with follow-up schedule, clinical assessments, and imaging
  • Simultaneous participation in another investigational study, unless at least 30 days beyond primary endpoint of previous study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 33 locations

1

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

UC San Diego

La Jolla, California, United States, 92037

Actively Recruiting

3

University of Southern California

Los Angeles, California, United States, 90031

Actively Recruiting

4

Stanford Hospitals and Clinics

Stanford, California, United States, 94305

Actively Recruiting

5

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

6

University of Florida Shands Hospital

Gainesville, Florida, United States, 32610

Actively Recruiting

7

Tampa General Hospital

Tampa, Florida, United States, 33606

Actively Recruiting

8

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

9

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

10

Endeavor Health Cardiovascular Institute at Glenbrook Hospital

Glenview, Illinois, United States, 60026

Actively Recruiting

11

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Actively Recruiting

12

Edward Hospital

Naperville, Illinois, United States, 60540

Actively Recruiting

13

Methodist Hospital of Indiana

Indianapolis, Indiana, United States, 46202

Actively Recruiting

14

University of Maryland

Baltimore, Maryland, United States, 21201

Actively Recruiting

15

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Completed

16

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

17

University of Massachusetts

Worcester, Massachusetts, United States, 01655

Actively Recruiting

18

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

19

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

20

Barnes Jewish Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

21

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

22

New York University Langone Medical Center

New York, New York, United States, 10016

Actively Recruiting

23

Columbia University Irving Medical Center/NY Presbyterian Hospital

New York, New York, United States, 10032

Actively Recruiting

24

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

25

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

26

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

27

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

28

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

29

Holston Valley Hospital

Kingsport, Tennessee, United States, 37660

Actively Recruiting

30

Ut Southwestern

Dallas, Texas, United States, 75235

Actively Recruiting

31

Memorial Hermann Texas Medical Center/UT Health

Houston, Texas, United States, 77030

Actively Recruiting

32

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States, 24014

Active, Not Recruiting

33

St Thomas' Hospital

London, United Kingdom, SE1 7EH

Active, Not Recruiting

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Research Team

C

Chanda Bell, RN, BSN

CONTACT

M

Maria Soerensen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Zenith® Fenestrated+ Clinical Study | DecenTrialz