Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Overview
- Phase
- Not Applicable
- Intervention
- Endovascular Branched Stent-Graft
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Sponsor
- Warren J. Gasper, MD
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Successful implantation of TAAA branched stent-graft.
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Detailed 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.
Investigators
Warren J. Gasper, MD
Associate Professor, Surgery
University of California, San Francisco
Eligibility Criteria
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.
- •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.
Arms & Interventions
Interventional
Endovascular Branched Stent-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).
Intervention: Endovascular Branched Stent-Graft
Outcomes
Primary Outcomes
Successful implantation of TAAA branched stent-graft.
Time Frame: 1 month
Secondary Outcomes
- Long term success of TAAA branched stent-graft treatment.(5 years)