Zenith® Fenestrated+ Clinical Study

Last updated: April 7, 2025
Sponsor: Cook Research Incorporated
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

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: 102
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:
April 30, 2031

Connect with a study center

  • St Thomas' Hospital

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • University of Alabama Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • UC San Diego

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90031
    United States

    Active - Recruiting

  • Stanford Hospitals and Clinics

    Stanford, California 94305
    United States

    Active - Recruiting

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • University of Florida Shands Hospital

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Active - Recruiting

  • Endeavor Health

    Naperville, Illinois 60540
    United States

    Active - Recruiting

  • Methodist Hospital of Indiana

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Massachusetts

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Barnes Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center/NY Presbyterian Hospital

    New York, New York 10032
    United States

    Active - Recruiting

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Holston Valley Hospital

    Kingsport, Tennessee 37660
    United States

    Active - Recruiting

  • Ut Southwestern

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Memorial Hermann Texas Medical Center/UT Health

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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