Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA (NCT02989948) | Clinical Trial Compass
RecruitingNot Applicable
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
United States80 participantsStarted 2020-04-22
Plain-language summary
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.
Who can participate
Age range50 Years – 95 Years
SexALL
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Inclusion 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 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
30 day survival
Timeframe: 30 Days
2
Major Adverse Events (MAE) at 30 days following surgery