Zenith® Fenestrated+ Clinical Study
- Conditions
- Extent IV ThoracoabdominalAortic Aneurysm, AbdominalJuxtarenal Aortic AneurysmPararenal Aneurysm
- Interventions
- Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
- Registration Number
- NCT04875429
- Lead Sponsor
- Cook Research Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aortic abdominal aneurysm Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 -
- Primary Outcome Measures
Name Time Method 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 strokeComposite 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
University of Alabama Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Stanford Hospitals and Clinics
🇺🇸Stanford, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
UC San Diego
🇺🇸La Jolla, California, United States
Endeavor Health
🇺🇸Naperville, Illinois, United States
Methodist Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Columbia University Irving Medical Center/NY Presbyterian Hospital
🇺🇸New York, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Holston Valley Hospital
🇺🇸Kingsport, Tennessee, United States
Ut Southwestern
🇺🇸Dallas, Texas, United States
Memorial Hermann Texas Medical Center/UT Health
🇺🇸Houston, Texas, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
St Thomas' Hospital
🇬🇧London, United Kingdom