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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Endovascular aneurysm repair
Composite measure of device technical success and procedural safety
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
Time frame: 30 days post procedure
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention
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)
Time frame: 12 months post procedure
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University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
UC San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Stanford Hospitals and Clinics
Stanford, California, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Endeavor Health Cardiovascular Institute at Glenbrook Hospital
Glenview, Illinois, United States
...and 23 more locations