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Zenith® Fenestrated+ Clinical Study

Recruiting

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the 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

What is being tested

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

Sponsor: Cook Research Incorporated · Participants: 105 · Started: Dec 8, 2023

Contact the study team

Chanda Bell, RN, BSN · Phone: 765-463-7537
Maria Soerensen · Phone: +45 2868 3248

Official record on ClinicalTrials.gov — NCT04875429

Locations in the U.S.

Alabama	University of Alabama Birmingham Hospital, Birmingham
California	UC San Diego, La Jolla University of Southern California, Los Angeles Stanford Hospitals and Clinics, Stanford
District of Columbia	Medstar Washington Hospital Center, Washington D.C.
Florida	University of Florida Shands Hospital, Gainesville Tampa General Hospital, Tampa
Georgia	Emory University Hospital, Atlanta
Illinois	Northwestern Memorial Hospital, Chicago Endeavor Health Cardiovascular Institute at Glenbrook Hospital, Glenview Loyola University Medical Center, Maywood Edward Hospital, Naperville
Indiana	Methodist Hospital of Indiana, Indianapolis
Maryland	University of Maryland, Baltimore
Massachusetts	Beth Israel Deaconess Medical Center, Boston University of Massachusetts, Worcester
Michigan	University of Michigan Health System, Ann Arbor
Minnesota	Mayo Clinic, Rochester
Missouri	Barnes Jewish Hospital, St Louis
New Hampshire	Dartmouth-Hitchcock Medical Center, Lebanon
New York	Columbia University Irving Medical Center/NY Presbyterian Hospital, New York New York University Langone Medical Center, New York
North Carolina	University of North Carolina at Chapel Hill, Chapel Hill
Ohio	Cleveland Clinic Foundation, Cleveland
Pennsylvania	Hospital of the University of Pennsylvania, Philadelphia University of Pittsburgh Medical Center, Pittsburgh
South Carolina	Medical University of South Carolina, Charleston
Tennessee	Holston Valley Hospital, Kingsport
Texas	Ut Southwestern, Dallas Memorial Hermann Texas Medical Center/UT Health, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.