Zenith(RegisteredTM) p-Branch[?] Multicenter Study
- Clements University Hospital
David Timaran Montenegro
Carlos Timaran, M.D.
This clinical investigation will be conducted as a prospective, non-randomized study and will enroll up
to 30 patients at up to 10 clinical sites.The primary objectives of this clinical investigation are descriptive and not for the purpose of statistical inference initially.This study is intended to provide early clinical experience with the Zenith[RegisteredTM] p-Branch to physicians while also evaluating device safety and effectiveness. no control group will be used.
A patient is deemed suitable for inclusion in the study if the patient has at least one the following:
1. Pararenal or juxtarenal AAA >=5.0 cm in diameter or 2 times the normal aortic diameter;
2. Pararenal or juxtarenal AAA with history of growth >=0.5 cm/year;
3. Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is
deemed to be at risk for rupture based upon physician interpretation.