Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Inclusion 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.

Exclusion Criteria:

- 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