The primary objective of this study is to assess the use of a physician-modified Cook Alpha
Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal
aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having
appropriate anatomy. The primary intent of the study is to assess the safety and preliminary
effectiveness of the device. Additionally, the study will assess renal function, radiation
exposure, and quality of life.
This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled
subject will undergo periodic follow-up evaluations involving physical exams, computed
tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound,
creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals
for a period of five years following the physician-modified Cook Zenith Alpha Endovascular
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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