Endovascular Repair of Descending Thoracic Aortic Aneurysms

Inclusion criteria

• Patient is a candidate for repair of a descending thoracic aortic aneurysm.
• Patient has one or more of the following:

• Descending thoracic aneurysm, 5 cm in diameter or greater with proximal and distal neck suitable for stent graft placement.
• Aneurysm is 4-5 cm in diameter but has increased in size by 0.5 cm in last 6 months.
• Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment.
• Post-traumatic pseudoaneurysm
• Post-surgical pseudoaneurysm
• Saccular aneurysm
• Contained rupture
• Penetrating ulcer
• Patient's vascular dimensions must be in the range that can be safely treated with the stent graft and extensions available to the physician at the time of the procedure.
• Patient has patent iliac or femoral arteries or acceptable retroperitoneal access via the abdominal aorta that allow endovascular access to the aneurysmal site with a 23F delivery catheter, typically used with a 25F introducer sheath
• Patient has a non-aneurysmal proximal and distal aortic neck diameter between 25 and 36 mm.
• Patient is American Society of Anesthesiology (ASA) grade 1 through 4.
• Patient has a stage of disease or condition where there is no comparable or satisfactory alternative device or therapy available for treatment; or the patient has an immediately life-threatening disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
• Patient is able and willing to comply with 1 month, 6 month, and 1 year follow-up, and willing to comply with annual post-treatment follow-up requirements thereafter.
• Patient or patient's legal representative understands and has signed an Informed Consent.

Exclusion criteria

• The stent graft would have to be positioned such that there would be no flow to an artery, major branch artery or major branch arteries which supply the spinal cord.
• The patient has congenital abnormalities in which the placement of the stent graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated prior to treatment.
• Patient is pregnant.
• Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
• Patient has connective tissue disease.
• Patient has a hypercoagulability disorder.
• Patient is in acute renal failure.
• Patient has active systemic infection.
• Patient is less than 18 years old.
• Patient has less than a one-year life expectancy.
• Patient is participating in another research study involving an investigational agent for the treatment of Descending Thoracic Aortic Aneurysms.
• Patient has other medical, social or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
• Patient is unwilling or unable to return for or comply with follow-up visit schedules.