Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in
high-risk patients. The purpose of this study is to determine whether this endovascular
prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in
patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will
be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram,
intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The
endovascular prosthesis is placed in the operating room under regional or general anesthesia
and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1
month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical
exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.

Inclusion Criteria:

- The aneurysm is >/= 5 cm or larger, or with a high risk of rupture due to its shape,
history of growth, symptoms, or the presence of a large (>2 cm) iliac aneurysm

- Anticipated mortality greater than 10 percent with conventional surgery

- Life expectancy greater than 2 years

- Suitable arterial anatomy

- Absence of systemic disease or allergy that precludes an endovascular repair

- Capable of giving informed consent and willingness to comply with the follow-up
schedule

Exclusion Criteria:

- Pregnancy

- History of anaphylactic reaction to contrast material with an inability to properly
prophylax the patient appropriately

- Allergy to stainless steel or polyester

- Unwilling to comply with the follow-up schedule

- Serious or systemic groin infection

- Coagulopathy, other than coumadin therapy

- Inability to give informed consent