Repairing complex abdominal aortic aneurysms with specialized stent grafts
Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts
This study is testing if special stent grafts can safely and effectively repair complex abdominal aortic aneurysms in patients with specific types of these aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT01937949 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical outcomes and quality of life for patients undergoing endovascular repair of complex abdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Grafts. It aims to gather preliminary safety and efficacy data that could inform future studies and product development. The focus is on patients with juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms that meet specific size and growth criteria.
Who should consider this trial
Good fit: Ideal candidates include adults with juxtarenal, suprarenal, or type IV thoracoabdominal aortic aneurysms that are at least 5.0 cm in diameter or have shown significant growth.
Not a fit: Patients under 18, those with a life expectancy of less than 2 years, or those unable to comply with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment options and outcomes for patients with complex aortic aneurysms.
How similar studies have performed: Other studies using similar endovascular approaches have shown promising results, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
General Inclusion Criteria * A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft: * Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter * Aneurysm with a history of growth ≥ 0.5 cm per year * Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation. General Exclusion Criteria * Less than 18 years of age * Unwilling to comply with the follow-up schedule * Inability or refusal to give informed consent by the patient or a legally authorized representative * Pregnant or breastfeeding * Life expectancy \< 2-years * Additional medical restrictions as specified in the Clinical Investigation Plan * Additional anatomical restrictions as specified in the Clinical Investigation Plan
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Active_not_recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Gustavo S. Oderich, MD — Baylor College of Medicine
- Study coordinator: Andrea C Martinez, MS
- Email: andrea.martinez@bcm.edu
- Phone: 713-798-6835
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.