Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°. Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months. Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group. Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
Official Title
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Eligibility Criteria
- - Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or - Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.
- - Less than 21 years of age, - Life expectancy less than 2 years, - Pregnant, - Religious cultural or other objection to the receipt of blood or blood products, - Unwilling to comply with follow-up schedule, - Unwillingness or inability to provide informed consent to both trial and procedure. - Patients not expected to live more than 2 years from enrollment - Patient has a ruptured aneurysm - Aneurysm extends above renal arteries - Proximal neck of aneurysm has significant loose thrombus associated with it - Patient with an acute or chronic aortic dissection or mycotic aneurysm - Patient has current non-localized infection (may be recruited following remission of the infection) - Patient is allergic to device materials - Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl - Patient is clinically and morbidly obese such that imaging would be severely adversely affected - Patient has renal failure (serum creatinine > 2.5 mg/dL) - Patient has an uncorrectable bleeding abnormality - Patient has unstable angina - Patient is receiving dialysis: - Inflammatory aneurysm - MI in last 6 months - End stage COPD - Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome) - Significant (>80%) renal artery stenosis which cannot be readily treated
Investigator(s)
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Contact
Jason Lee
6507255227
View on ClinicalTrials.gov