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Zenith® Fenestrated+ Clinical Study

Cook Research Incorporated · NCT04875429

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
105
US sites recruiting
30
Study start
December 8, 2023
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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 130 additional subjects may be enrolled in Continued Access phase of the study

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

Conditions: Aortic Aneurysm, Abdominal; Juxtarenal Aortic Aneurysm; Extent IV Thoracoabdominal; Pararenal Aneurysm

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Exclusion Criteria

  • Age \< 18 years
  • Life expectancy \< 2 years
  • Pregnant, breast-feeding, or planning to become pregnant within 60 months
  • Inability or refusal to give informed consent by the patient or legally authorized representative
  • Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
  • Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Recruiting US locations

  • University of Alabama Birmingham Hospital

    Birmingham, AL 35294

    Site contact: Adam Beck, MD

  • UC San Diego

    La Jolla, CA 92037

    Site contact: Mahmoud Malas, MD

  • University of Southern California

    Los Angeles, CA 90031

    Site contact: Sukgu Han, MD

  • Stanford Hospitals and Clinics

    Stanford, CA 94305

    Site contact: Jason Lee, MD

  • Medstar Washington Hospital Center

    Washington D.C., DC 20010

    Site contact: Steven Abramowitz, MD

  • University of Florida Shands Hospital

    Gainesville, FL 32610

    Site contact: Zain Shahid, MD

  • Tampa General Hospital

    Tampa, FL 33606

    Site contact: Dean Arnaoutakis, MD

  • Emory University Hospital

    Atlanta, GA 30322

    Site contact: Yazan Duwayri, MD

  • Northwestern Memorial Hospital

    Chicago, IL 60611

    Site contact: Neel Mansukhani, MD

  • Endeavor Health Cardiovascular Institute at Glenbrook Hospital

    Glenview, IL 60026

    Site contact: George Pontikis

  • Loyola University Medical Center

    Maywood, IL 60153

    Site contact: Michael Soult, MD

  • Edward Hospital

    Naperville, IL 60540

    Site contact: George Pontikis, MD

  • Methodist Hospital of Indiana

    Indianapolis, IN 46202

    Site contact: Andres Fajardo, MD

  • University of Maryland

    Baltimore, MD 21201

    Site contact: Shahab Toursavadkohi, MD

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Marc Schermerhorn, MD

  • University of Massachusetts

    Worcester, MA 01655

    Site contact: Andres Schanzer, MD

  • University of Michigan Health System

    Ann Arbor, MI 48109

    Site contact: Jonathan Eliason, MD

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Randall DeMartino, MD

  • Barnes Jewish Hospital

    St Louis, MO 63110

    Site contact: John Ohman, MD

  • Dartmouth-Hitchcock Medical Center

    Lebanon, NH 03756

    Site contact: Bjoern Suckow, MD

  • New York University Langone Medical Center

    New York, NY 10016

    Site contact: Thomas Maldonado, MD

  • Columbia University Irving Medical Center/NY Presbyterian Hospital

    New York, NY 10032

    Site contact: Virenda Patel

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27599

    Site contact: Federico Parodi, MD

  • Cleveland Clinic Foundation

    Cleveland, OH 44195

    Site contact: Francis Caputo, MD

  • Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Grace Wang, MD

  • University of Pittsburgh Medical Center

    Pittsburgh, PA 15213

    Site contact: Nathan Liang

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Ravi Veeraswamy, MD

  • Holston Valley Hospital

    Kingsport, TN 37660

    Site contact: Robert "Bo" Allen, MD

  • Ut Southwestern

    Dallas, TX 75235

    Site contact: Mirza Baig, MD

  • Memorial Hermann Texas Medical Center/UT Health

    Houston, TX 77030

    Site contact: Naveed Saqib, MD

Study contacts (from the official record)

  • Chanda Bell, RN, BSN · 765-463-7537 · chanda.bell@cookmedical.com
  • Maria Soerensen · +45 2868 3248 · maria.soerensen@cookmedical.com
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Zenith® Fenestrated+ Clinical Study (NCT04875429) | Bored Studies