Zenith® Fenestrated+ Clinical Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Cook Research Incorporated
Study ID: NCT04875429
Status: Recruiting

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Conditions

Aortic Aneurysm, Abdominal
Extent IV Thoracoabdominal
Juxtarenal Aortic Aneurysm
Pararenal Aneurysm

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Key Dates

Start date: Dec 8, 2023
Status verified: Mar 2026
Primary completion: Nov 30, 2026
Completion: Nov 30, 2031

Study Design

Enrollment: 105 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Aortic abdominal aneurysm

Primary Outcome Measure

Composite measure of device technical success and procedural safety [ Time Frame: 30 days post procedure ]

Central Contacts

Chanda Bell, RN, BSN
765-463-7537
[email protected]
Maria Soerensen
+45 2868 3248
[email protected]

Locations (32)

Facility	City	State	ZIP	Site coordinators
University of Alabama Birmingham Hospital	Birmingham	Alabama	35294	Adam Beck, MD
UC San Diego	La Jolla	California	92037	Mahmoud Malas, MD
University of Southern California	Los Angeles	California	90031	Sukgu Han, MD
Stanford Hospitals and Clinics	Stanford	California	94305	Jason Lee, MD
Medstar Washington Hospital Center	Washington D.C.	District of Columbia	20010	Steven Abramowitz, MD
University of Florida Shands Hospital	Gainesville	Florida	32610	Zain Shahid, MD
Tampa General Hospital	Tampa	Florida	33606	Dean Arnaoutakis, MD
Emory University Hospital	Atlanta	Georgia	30322	Yazan Duwayri, MD
Northwestern Memorial Hospital	Chicago	Illinois	60611	Neel Mansukhani, MD
Endeavor Health Cardiovascular Institute at Glenbrook Hospital	Glenview	Illinois	60026	George Pontikis
Loyola University Medical Center	Maywood	Illinois	60153	Michael Soult, MD
Edward Hospital	Naperville	Illinois	60540	George Pontikis, MD George Pontikis, MD (PRINCIPAL_INVESTIGATOR)
Methodist Hospital of Indiana	Indianapolis	Indiana	46202	Andres Fajardo, MD
University of Maryland	Baltimore	Maryland	21201	Shahab Toursavadkohi, MD
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	Marc Schermerhorn, MD
Massachusetts General Hospital	Boston	Massachusetts	02114	-
University of Massachusetts	Worcester	Massachusetts	01655	Andres Schanzer, MD
University of Michigan Health System	Ann Arbor	Michigan	48109	Jonathan Eliason, MD
Mayo Clinic	Rochester	Minnesota	55905	Randall DeMartino, MD
Barnes Jewish Hospital	St Louis	Missouri	63110	John Ohman, MD
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03756	Bjoern Suckow, MD
Columbia University Irving Medical Center/NY Presbyterian Hospital	New York	New York	10032	-
New York University Langone Medical Center	New York	New York	10016	Thomas Maldonado, MD
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	Federico Parodi, MD
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Francis Caputo, MD
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	Grace Wang, MD
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15213	-
Medical University of South Carolina	Charleston	South Carolina	29425	Ravi Veeraswamy, MD
Holston Valley Hospital	Kingsport	Tennessee	37660	Robert "Bo" Allen, MD
Ut Southwestern	Dallas	Texas	75235	Carlos Timaran, MD
Memorial Hermann Texas Medical Center/UT Health	Houston	Texas	77030	Naveed Saqib, MD
Carilion Roanoke Memorial Hospital	Roanoke	Virginia	24014	-

Find similar trials in Birmingham, AL

By research site

University of Alabama Birmingham Hospital· Birmingham, AL UC San Diego· La Jolla, CA University of Southern California· Los Angeles, CA Stanford Hospitals and Clinics· Stanford, CA Medstar Washington Hospital Center· Washington D.C., DC University of Florida Shands Hospital· Gainesville, FL

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