Endovascular treatment for thoracoabdominal and paravisceral aortic aneurysms
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
This study is testing a less invasive way to treat certain types of aortic aneurysms using a stent-graft to see if it can reduce pain and recovery time compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT00483249 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of an endovascular approach to treat thoracoabdominal and paravisceral abdominal aortic aneurysms. The procedure involves placing a stent-graft over the aneurysm through small incisions in the groins and arm, as opposed to traditional surgery which requires a large incision. The goal is to reduce pain, minimize complications, and shorten hospital stays compared to standard surgical methods. Participants will be monitored for outcomes related to the success of the stent-graft placement and overall recovery.
Who should consider this trial
Good fit: Ideal candidates include individuals with significant aortic aneurysms who meet specific size and anatomical criteria and have a life expectancy of more than two years.
Not a fit: Patients with free ruptures of the aneurysm, pregnancy, or serious systemic infections are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment option with fewer complications for patients with aortic aneurysms.
How similar studies have performed: Other studies have shown promising results with endovascular techniques for aortic aneurysms, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California and 1 other locations
- Division of Vascular Surgery, SFVAMC — San Francisco, California, United States (Recruiting)
- Division of Vascular Surgery, UCSF — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Warren J Gasper, MD — University of California, San Francisco
- Study coordinator: Warren J Gasper, MD
- Email: warren.gasper@ucsf.edu
- Phone: 415 750 2115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.