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
Parallel
Cook Custom Aortic Endograft
DeviceThe Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal aorta, thoracoabdominal aorta, or the aortic arch aorta. Grafts may include a combination of up to 5 fenestrations and/or branches.
Zenith t-Branch Endovascular Graft
DeviceThe Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.
Surgeon-Modified Endograft
DeviceThe Surgeon-Modified Endografts are created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.
Rate of major adverse events at 30 days post primary procedure
Rate of all-cause mortality in peri-operative period
Rate of all-cause mortality at 30 days post primary procedure
Number of major adverse events at 6 months post primary procedure
Number of subjects requiring ventilation more than 48 hours in peri-operative period
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University of Alabama at Birmingham
Lead sponsor
Cook Group Incorporated
Collaborator
