Actively Recruiting
Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
Led by University of California, Los Angeles · Updated on 2025-12-15
50
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an endovascular treatment for aortic aneurysms located near the kidneys and in the thoracoabdominal region. The study focuses on physician-modified stent grafts that combine fenestrations and branches to treat juxtarenal, pararenal, and thoracoabdominal aortic aneurysms, including those involving the iliac artery. This study aims to understand outcomes and major adverse events in patients receiving these specialized grafts, sponsored by the University of California, Los Angeles. Participants will receive investigational treatment using physician-modified stent grafts such as Cook Alpha TX2, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft. These grafts use multiple components with fenestrations and/or branches to repair the aneurysms. The study includes three groups based on aneurysm location and urgency: those with short neck infrarenal to extent IV thoracoabdominal aneurysms, those with extent I to III thoracoabdominal aneurysms, and those needing urgent or emergency repair within 48 hours. All participants will undergo repair using the investigational grafts. During the study, patients will be monitored for major adverse events within 30 days and treatment success at 12 months. Quality of life will be assessed at baseline, 30 days, 6 months, and then annually for up to 5 years. Follow-up includes clinical evaluations to track health changes and device performance. Participation may last several years, allowing researchers to gather long-term safety and effectiveness data for these physician-modified stent grafts.
CONDITIONS
Brief Title
Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with juxtarenal, pararenal, suprarenal, or thoracoabdominal aortic aneurysm or dissection meeting size or growth criteria
- Considered high risk for open surgical repair due to conditions such as age over 75, chronic obstructive pulmonary disease, congestive heart failure, previous heart procedures, chronic kidney insufficiency, or high anesthesia risk
- History of prior abdominal operations, abdominal wall reconstruction, radiation therapy to abdomen/pelvis, or intraabdominal sepsis
- Suitable for urgent or emergent repair within 48 hours if indicated and able to give informed consent
- Able and willing to comply with follow-up visits and study procedures
You will not qualify if you...
- Under 18 years of age
- Unwilling or unable to comply with follow-up schedule
- Unable or refusing to give informed consent
- Pregnant or breastfeeding
- Life expectancy less than 2 years
- Recent open surgical or interventional procedures within 30 days unless planned staged procedures for repair access
- Eligible for treatment with any FDA-approved marketed device per instructions
- Currently enrolled or eligible for other investigational clinical or device trials not compatible with this study
- Allergies or sensitivities to device materials such as stainless steel, nitinol, polyester, or contrast agents
- Uncorrectable blood clotting problems
- Active systemic infection or mycotic aneurysm
- History of connective tissue disorders affecting vascular system unless certain conditions apply
- Body size or anatomy preventing imaging or device placement
- Inadequate femoral or iliac artery access or unsuitable vessel anatomy for device placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours for urgent or emergent repair, or as scheduled for elective repair
Participants undergo repair of their aortic aneurysms using physician-modified fenestrated and branched stent grafts.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for major adverse events and treatment success after the stent graft procedure.
Visits at 30 days, 6 months, and annually up to 5 years
Trial Site Locations
Total: 1 location
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
K
Kate M Horiuchi, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here