This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels.
The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.
Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.
Diameter > 5.5 cm if asymptomatic, or 5.0 cm with enlargement of > 0.5 cm in 6 months.
History of growth > 0.5 cm per year
Any size if ruptured or symptomatic
Less than 18 years of age
Life expectancy less than 12 months based on the surgeon's assessment
Pregnant or breastfeeding or planning on becoming pregnant within 60 months
Inability or refusal to give informed consent
University of Alabama at Birmingham
Lead sponsor
Cook Group Incorporated
Collaborator