The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment.
The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
Patient is > 18 years of age
Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
Aortic aneurysm with diameter ≥ 5.5cm
Patient has a mycotic aneurysm
Patient has a ruptured aneurysm requiring urgent or emergent repair
Patient has a systemic or local infection that may increase the risk of graft infection
Patient has a body habitus that would inhibit X-ray visualization of the aorta.
University of California, Davis
Lead sponsor
University of California, San Diego
Collaborator