Zenith® Fenestrated+ Clinical Study

Recruiting now · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm

In brief

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 facts

Study ID

NCT04875429

Run by

Cook Research Incorporated

People needed

105

Starts

2023-12-08

Expected to finish

2031-11-01

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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