Zenith® Fenestrated+ Clinical Study

Last updated: February 6, 2026
Sponsor: Cook Research Incorporated
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiovascular Disease

Heart Disease

Aneurysm

Treatment

Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System

Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2

Clinical Study ID

NCT04875429
17-07
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Include Criteria:

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

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

  3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2xthe normal aortic diameter or saccular aneurysm that warrants treatment in theopinion of the investigator

Exclusion

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 authorizedrepresentative

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

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

Study Design

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System
Phase:
Study Start date:
December 08, 2023
Estimated Completion Date:
November 30, 2031

Connect with a study center

  • St Thomas' Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • St Thomas' Hospital

    London 2643743, SE1 7EH
    United Kingdom

    Site Not Available

  • University of Alabama Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama Birmingham Hospital

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Site Not Available

  • UC San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90031
    United States

    Site Not Available

  • Stanford Hospitals and Clinics

    Stanford, California 94305
    United States

    Site Not Available

  • UC San Diego

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • University of Southern California

    Los Angeles 5368361, California 5332921 90031
    United States

    Site Not Available

  • Stanford Hospitals and Clinics

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • University of Florida Shands Hospital

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • University of Florida Shands Hospital

    Gainesville 4156404, Florida 4155751 32610
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Endeavor Health

    Naperville, Illinois 60540
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Endeavor Health Cardiovascular Institute at Glenbrook Hospital

    Glenview 4893886, Illinois 4896861 60026
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood 4901514, Illinois 4896861 60153
    United States

    Site Not Available

  • Edward Hospital

    Naperville 4903279, Illinois 4896861 60540
    United States

    Site Not Available

  • Edwards Hospital

    Naperville 4903279, Illinois 4896861 60540
    United States

    Site Not Available

  • Endeavor Health

    Naperville 4903279, Illinois 4896861 60540
    United States

    Site Not Available

  • Methodist Hospital of Indiana

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Methodist Hospital of Indiana

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Maryland

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Massachusetts

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • University of Massachusetts

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Barnes Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Barnes Jewish Hospital

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

  • Columbia University Irving Medical Center/NY Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center/NY Presbyterian Hospital

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • New York University Langone Medical Center

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Holston Valley Hospital

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Holston Valley Hospital

    Kingsport 4634662, Tennessee 4662168 37660
    United States

    Site Not Available

  • Ut Southwestern

    Dallas, Texas 75235
    United States

    Site Not Available

  • Memorial Hermann Texas Medical Center/UT Health

    Houston, Texas 77030
    United States

    Site Not Available

  • Ut Southwestern

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • Memorial Hermann Texas Medical Center/UT Health

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Carilion Roanoke Memorial Hospital

    Roanoke 4782167, Virginia 6254928 24014
    United States

    Site Not Available

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