Jesse Manunga, MD
The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).
The study is a prospective, non-randomized evaluation of endovascular repair of patients with failed previous infrarenal repairs (failed EVAR) and complex thoracoabdominal/juxtarenal/pararenal/paravisceral aortic aneurysm repair, including those with penetrating ulcers and aneurysms resulting from aortic dissections, who (1) have anatomy that is not suitable for endovascular repair using grafts currently marketed in the United States, (2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Depending o…
Inclusion Criteria: * Age: ≥ 18 years old * The subject has one or more of the following: 1\. An aneurysm with a maximum diameter of \> 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements 2. Aneurysm with a history of growth \> 0.5 cm in 6 months or clinically indicated for repair based on symptoms 3. Symptomatic aneurysm 4. Ruptured aneurysm 6. Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss 7. Saccular ane…
Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components.
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