Zenith® Fenestrated+ Clinical Study

March 19, 2026 updated by: Cook Research Incorporated

Zenith® Fenestrated+ Endovascular Graft Clinical Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Active, not recruiting
        • St Thomas' Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham Hospital
        • Contact:
          • Adam Beck, MD
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego
        • Contact:
          • Mahmoud Malas, MD
      • Los Angeles, California, United States, 90031
        • Recruiting
        • University of Southern California
        • Contact:
          • Sukgu Han, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Hospitals and Clinics
        • Contact:
          • Jason Lee, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
        • Contact:
          • Steven Abramowitz, MD
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Shands Hospital
        • Contact:
          • Zain Shahid, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Contact:
          • Dean Arnaoutakis, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
          • Yazan Duwayri, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
          • Neel Mansukhani, MD
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Endeavor Health Cardiovascular Institute at Glenbrook Hospital
        • Contact:
          • George Pontikis
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Michael Soult, MD
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Edward Hospital
        • Contact:
          • George Pontikis, MD
        • Principal Investigator:
          • George Pontikis, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Methodist Hospital of Indiana
        • Contact:
          • Andres Fajardo, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
          • Shahab Toursavadkohi, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Marc Schermerhorn, MD
      • Boston, Massachusetts, United States, 02114
        • Completed
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Contact:
          • Andres Schanzer, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System
        • Contact:
          • Jonathan Eliason, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Randall DeMartino, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes Jewish Hospital
        • Contact:
          • John Ohman, MD
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Contact:
          • Bjoern Suckow, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Langone Medical Center
        • Contact:
          • Thomas Maldonado, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center/NY Presbyterian Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
          • Federico Parodi, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
          • Francis Caputo, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
          • Grace Wang, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Ravi Veeraswamy, MD
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Holston Valley Hospital
        • Contact:
          • Robert "Bo" Allen, MD
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern
        • Contact:
          • Carlos Timaran, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Texas Medical Center/UT Health
        • Contact:
          • Naveed Saqib, MD
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Active, not recruiting
        • Carilion Roanoke Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of device technical success and procedural safety
Time Frame: 30 days post procedure

Percent of patients with device technical success and freedom from procedural safety events in the following criteria:

  1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and
  2. Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
30 days post procedure
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention
Time Frame: 12 months post procedure

Percent of patients meeting the following criteria:

  1. Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and
  2. Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)
12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Research Incorporated

Investigators

  • Principal Investigator: Gustavo Oderich, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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