Repairing complex abdominal aortic aneurysms with specialized stent grafts
Official title: Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts
Run by Baylor College of Medicine · NCT01937949 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Status | Recruiting |
| Started | August 2013 |
| Main results expected | March 2025 |
| Study ends | May 2030 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT01937949 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies using similar endovascular approaches have shown promising results, indicating potential for success in this area.
Who can join: the full rules
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 it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Active not 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
GelPOINT Path-assisted endoscopic removal of colorectal polyps
This study tests whether using the GelPOINT Path access platform during endoscopic submucosal dissection can safely help remove colorectal polyps in adults.
-
Acceptance Based Coping Skills for Hispanic/Latino Military Patients With Type 2 Diabetes
A bilingual health coach will lead a 10-week telehealth program to help Hispanic/Latino military patients with type 2 diabetes manage their condition better.
-
Postoperative Pain After Pediatric Adenotonsillectomy: Ibuprofen Plus Tylenol vs Ketorolac Plus Tylenol
This observational study will see if teens (13-18) who have adenotonsillectomy and take acetaminophen with ibuprofen or acetaminophen with ketorolac after discharge experience different levels of pain and recovery.
-
Non-invasive brain stimulation to try to improve memory in early Alzheimer's
Scientists test whether repetitive transcranial magnetic stimulation to the cerebellum can help short-term memory in people with early Alzheimer's disease compared with a sham procedure.
-
Using a steroid cream to prevent repeat urinary tract infections in uncircumcised baby boys
This pilot will test whether applying a steroid cream twice weekly for four weeks can help prevent repeat urinary tract infections in uncircumcised male infants under 6 months who have had a first UTI.
-
Speedboat UltraSlim™ for POEM in adults with achalasia and other esophageal motility disorders.
This registry will see if using the Speedboat UltraSlim™ device for POEM is safe and effective for adults with achalasia or other esophageal motility disorders.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.