The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Treatment Success Proportion
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
Time frame: 12 months
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University of Alabama Birmingham Hosptial
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center-Dignity Health
Phoenix, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Kaiser Permanente
San Francisco, California, United States
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Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Boca Raton Community Hospita
Boca Raton, Florida, United States
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Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
...and 17 more locations