Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)
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 judgment of the S-I, to be a high risk candidate for open surgical repair.
• Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
• Must be able to provide informed consent.
• Must be able to comply with the five year study assessment schedule of events.
• Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, 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.
• 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 S-I, has aneurysm characteristics that portend a high risk of near-term rupture
• Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair
• Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
• Patient must be able to provide informed consent
• Must be able to comply with the five year study assessment schedule of events
• Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years