Zenith® Fenestrated+ Clinical Study
Zenith® Fenestrated+ Endovascular Graft Clinical Study
1 other identifier
interventional
105
2 countries
33
Brief 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. Up to 60 additional subjects may be enrolled in Continued Access phase of the study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 6, 2021
CompletedStudy Start
First participant enrolled
December 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2031
March 23, 2026
March 1, 2026
2.9 years
April 19, 2021
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composite measure of device technical success and procedural safety
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
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
Study Arms (1)
Aortic abdominal aneurysm
EXPERIMENTALInterventions
Endovascular aneurysm repair
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35294, United States
UC San Diego
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90031, United States
Stanford Hospitals and Clinics
Stanford, California, 94305, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida Shands Hospital
Gainesville, Florida, 32610, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Endeavor Health Cardiovascular Institute at Glenbrook Hospital
Glenview, Illinois, 60026, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Edward Hospital
Naperville, Illinois, 60540, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Columbia University Irving Medical Center/NY Presbyterian Hospital
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Holston Valley Hospital
Kingsport, Tennessee, 37660, United States
Ut Southwestern
Dallas, Texas, 75235, United States
Memorial Hermann Texas Medical Center/UT Health
Houston, Texas, 77030, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
St Thomas' Hospital
London, SE1 7EH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gustavo Oderich, MD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2021
First Posted
May 6, 2021
Study Start
December 8, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2031
Last Updated
March 23, 2026
Record last verified: 2026-03