Overview
This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.
Description
A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.
Eligibility
Inclusion Criteria
- Aortic aneurysms:
- greater than or equal to 6 cm in diameter in men,
- greater than or equal to 5.5 cm in diameter in women,
- and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,
- and/or iliac aneurysms larger than 4 cm in diameter.
- Anticipated mortality comparable to published rates with conventional surgical
treatment.
- Life expectancy more than 2 years.
- Ability to give informed consent.
- Willingness to comply with follow-up schedule.
- Suitable arterial anatomy for endovascular repair.
Exclusion Criteria
- Free rupture of the aneurysm.
- Pregnancy.
- Known allergy to Nitinol, stainless steel, or polyester.
- Unwillingness or inability to comply with the follow up schedule.
- Serious systemic or groin infection.
- Uncorrectable coagulopathy.