Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)

Inclusion Criteria: - Anatomic (stent-graft) Aortic Aneurysm Diameter > 4.5 cm Those aortic aneurysms < 4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment. Aorto-iliac aneurysms in which the aortic aneurysm is < 4.5 cm but the iliac artery aneurysms are > 3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms < 3.0 cm. Saccular aortic aneurysms > 3.0 cm. Aortic Neck Diameter > 17 mm and < 28 mm (Phase I) Diameter > 14 mm and < 28 mm (Phase II) Angulation Neck Length < 45° > 15 mm <60° > 25 mm Iliac Arteries Diameter > 8 mm and < 18 mm (Phase I and Phase II) At least one common iliac artery with a cuff > 15 mm. Diameter Aortic Neck Common Iliac 26-28 mm 13-18 mm 23-25.9 mm 10-17 mm 20-22.9 mm 9-15 mm 17-19.9 mm 8-13 mm 14-16.9 mm 8-11mm *NOTE: An aortic diameter cannot be treated if the iliac diameter is not in the same range (e.g. 26-28 mm aortic necks must be in conjunction with 13-18 mm common iliacs). Anatomic (surgical controls) · Surgical controls will be required to meet only the aortic or aorto-iliac aneurysm size requirements for anatomic inclusion criteria. Aortic Aneurysm Diameter > 4.5 cm Those aortic aneurysms <4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment. Aorto-iliac aneurysm in which the aortic aneurysm is <4.5 cm but the iliac artery aneurysm are >3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms <3.0 cm. Saccular aortic aneurysms > 3.0 cm. Clinical (stent-graft) Males and non-pregnant females > 40 years of age. Clinical (surgical controls) Surgical control patients will be required to meet all of the above-stated stent-graft clinical inclusion criteria. Exclusion Criteria: Anatomic (stent-graft) Aortic Aneurysm Diameter · < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period. Aorto-iliac Aneurysms < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period). The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate covering both internal iliac arteries with the device. Aortic Neck Diameter < 17 mm and > 28 mm (Phase I) Diameter < 14 and >28 (Phase II) Thrombus lined Highly calcified NOTE: See inclusion criteria for length below the renals and degree of angulation. Iliac Arteries < 8 mm and > 18 mm (native) (Phase I and Phase II) Highly calcified (common) Neither common iliac artery with a cuff > 15 mm. NOTE: See inclusion criteria for aortic neck and iliac artery diameters. Anatomic (surgical controls) · Surgical controls will be excluded based only on the aortic or aorto-iliac aneurysm size requirements for anatomic exclusion criteria. Aortic Aneurysm Diameter · < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period. Aorto-Iliac Aneurysms < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period). The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate surgically covering both internal iliac arteries. Clinical (stent-graft) Ruptured abdominal aortic aneurysm. Renal insufficiency - creatinine level > 2.5 mg/dl.