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.