Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

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