Zenith® Fenestrated+ Clinical Study

NCT04875429 · tracked via the Priya Life Science UK tracker

Sponsor

Cook Research Incorporated

Phase

Not applicable

Started

2023-12-08

Last updated

2026-09-17

Condition(s) studied

Aortic Aneurysm, AbdominalJuxtarenal Aortic AneurysmExtent IV ThoracoabdominalPararenal Aneurysm

Investigational drug(s) / intervention(s)

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

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

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.

Up to 60 additional subjects may be enrolled in Continued Access phase of the study

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Composite measure of device technical success and procedural safety — 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
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention — 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)

Trial sites (33)

Facility	City	Region	Status
University of Alabama Birmingham Hospital	Birmingham	Alabama	Recruiting
UC San Diego	La Jolla	California	Recruiting
University of Southern California	Los Angeles	California	Recruiting
Stanford Hospitals and Clinics	Stanford	California	Recruiting
Medstar Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
University of Florida Shands Hospital	Gainesville	Florida	Recruiting
Tampa General Hospital	Tampa	Florida	Recruiting
Emory University Hospital	Atlanta	Georgia	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	Recruiting
Endeavor Health Cardiovascular Institute at Glenbrook Hospital	Glenview	Illinois	Recruiting
Loyola University Medical Center	Maywood	Illinois	Recruiting
Edward Hospital	Naperville	Illinois	Recruiting
Methodist Hospital of Indiana	Indianapolis	Indiana	Recruiting
University of Maryland	Baltimore	Maryland	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Completed
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
University of Massachusetts	Worcester	Massachusetts	Recruiting
University of Michigan Health System	Ann Arbor	Michigan	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
Barnes Jewish Hospital	St Louis	Missouri	Recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	Recruiting
New York University Langone Medical Center	New York	New York	Recruiting
Columbia University Irving Medical Center/NY Presbyterian Hospital	New York	New York	Recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Holston Valley Hospital	Kingsport	Tennessee	Recruiting
Ut Southwestern	Dallas	Texas	Recruiting
Memorial Hermann Texas Medical Center/UT Health	Houston	Texas	Recruiting
Carilion Roanoke Memorial Hospital	Roanoke	Virginia	Active Not Recruiting
St Thomas' Hospital	London	United Kingdom	Active Not Recruiting

More Cook Research Incorporated trials in the UK

Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study Recruiting

European Aortic Data Collection Project Recruiting

Other trials for the same condition

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04875429 on ClinicalTrials.gov ↗ ← All trials in the UK