Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Eligibility Criteria

• * Must be a man or woman 50 years of age or older by the date of informed consent
• * Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
• * Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta)
• * Must be considered, in the judgement of the Investigator, to be a high- risk candidate for open surgical repair
• * Must commit to comply with the five-year study assessment schedule of events
• * Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years
• * Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection
• * Ruptured or acutely symptomatic aortic aneurysm
• * Known connective tissue disorder
• * Imaging demonstrating any of the following:
• * Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition)
• * Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac)
• * Branch vessel target (renal, superior mesenteric, or celiac) \< 5 mm or \> 10 mm in average diameter
• * Untreated left subclavian artery stenosis or occlusion
• * Untreated unilateral or bilateral hypogastric artery occlusion
• * Signs that the inferior mesenteric artery is indispensable
• * Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices
• * Known allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
• * History of anaphylaxis to contrast, with inability to prophylax appropriately.
• * Have uncorrectable coagulopathy
• * Have unstable angina
• * Have a body habitus that would inhibit X-ray visualization of the aorta
• * Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair
• * Known to be participating in any other clinical study which may affect performance of this - Ability to bear children
• * Contraindication to oral antiplatelet therapy
• * Prisoners or those on alternative sentencing
• * Known systemic infection with potential for endovascular graft infection
• * Anticipated need for MRI scanning within 3 months of insertion of investigational product
• * Candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
• * Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution.