NCT00483249 Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
| NCT ID | NCT00483249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Warren J. Gasper, MD |
| Condition | Thoracoabdominal Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2005-05 |
| Primary Completion | 2027-12 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria 1. 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. 2. Anticipated mortality comparable to published rates with conventional surgical treatment. 3. Life expectancy more than 2 years. 4. Ability to give informed consent. 5. Willingness to comply with follow-up schedule. 6. Suitable arterial anatomy for endovascular repair. Exclusion Criteria 1. Free rupture of the aneurysm. 2. Pregnancy. 3. Known allergy to Nitinol, stainless steel, or polyester. 4. Unwillingness or inability to comply with the follow up schedule. 5. Serious systemic or groin infection. 6. Uncorrectable coagulopathy.