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.
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.
You CAN'T join if...
Less than 21 years of age,
Life expectancy less than 2 years,
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:
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
UCSF Division of Vascular Surgery San Francisco, California, 94143, USA
Stanford University Medical Center Stanford, California, 94305, USA
Long Beach VA Healthcare System Long Beach, California, 90822, USA
Harbor-UCLA Medical Center Torrance, California, 90502, USA