Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.
• 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
• Must be a man or woman 50 years of age or older by the date of informed consent
• Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and/or distal seal. The aneurysm must not extend proximal to the left subclavian artery, or, in the setting of more proximal disease, that disease must have been previously treated.
• Must have an aneurysm size that meets standard size 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); or, in the judgment of the Investigator, has aneurysm characteristics that portend a high risk of near-term rupture
• In the setting of an aortic dissection the following criteria must exist:
‣ Access into the true lumen from the groin and at least one supra-aortic trunk vessel
⁃ A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent graft would be anticipated to seal off the dissection lumen
⁃ A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created
⁃ A true lumen size large enough to deploy the device and still gain access into the target branches
• Must be considered, in the judgement of the Investigator, to be a high-risk candidate for open surgical repair
• Patient must be able to provide informed consent
• 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