Actively Recruiting
Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study
Led by Jonathan Bath · Updated on 2025-03-28
15
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
J
Jonathan Bath
Lead Sponsor
U
University of Missouri-Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a new device called the LIFE device for treating aneurysms in the aorta, which is the large blood vessel carrying blood from the heart to the body. The study focuses on people with aneurysms near the kidney arteries, known as juxtarenal or pararenal aortic aneurysms, who are not eligible for currently approved endovascular or open repairs. It investigates whether the LIFE device works for these aneurysms and what medical issues may occur during its use. Participants will receive treatment using the LIFE device, which is placed endovascularly through blood vessels in the groin. The device covers the aneurysm tear or leak and includes side branches that allow blood flow to important arteries for the kidneys, spleen, intestines, or liver. This trial enrolls patients who cannot use other approved devices and are unwilling or unable to travel to sites with manufacturer-made devices. The treatment is a fenestrated endovascular aneurysm repair using the LIFE device system. After treatment, participants will have follow-up visits at 30 days, 6 months, 1 year, and annually up to 5 years. During these visits, pulses will be checked, blood tests will assess kidney function, and CT scans will monitor the aneurysm area. The study measures include freedom from death and major adverse events within 30 days, technical success of the device procedure, and absence of complications such as leaks or device migration up to 12 months. Long-term monitoring continues for up to 5 years to evaluate device performance and safety.
CONDITIONS
Brief Title
Laser In Situ Fenestration Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aortic aneurysm larger than 5.5 cm in men or larger than 5.0 cm in women, or rapid expansion with risk of rupture near the kidney arteries
- Need for endovascular aortic repair covering renovisceral branches
- Not a candidate or high risk for open repair due to conditions like renal dysfunction, previous surgeries, obesity, heart risk, COPD, diabetes, smoking, or blood thinner use
- Suitable aortic landing zone and vessel sizes for device placement
- Anatomy suitable for aneurysm exclusion using laser fenestration
- Not willing or able to travel to sites with manufacturer-made investigational devices
- Not a candidate for currently approved endovascular options
- 18 years or older
- Able to provide informed consent and HIPAA authorization
- Willing and able to attend all study visits and follow-ups
You will not qualify if you...
- Allergies or sensitivities to device materials such as Nitinol, polyester, platinum-iridium, stainless steel, fluoropolymer, or heparin
- Known allergy or contraindication to anticoagulation or contrast media that cannot be managed
- Uncorrectable blood clotting disorders
- Body size or shape that prevents safe imaging or device use
- Participation in another experimental therapy research
- Judged unsuitable by the investigator for any reason
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo Fenestrated Endovascular Aneurysm Repair using the LIFE Device System to treat their aortic aneurysms.
1 visit (procedure day)
Duration - Up to 12 months and ongoing assessments up to 5 years
Participants are monitored for recovery and any adverse events following the procedure.
Multiple visits including assessments at 30 days, 6 months, 12 months, and annually up to 5 years
Trial Site Locations
Total: 1 location
1
University of Missouri - Columbia
Columbia, Missouri, United States, 65212
Actively Recruiting
Research Team
J
Jennifer Randolph, Nurse, Clinical Research, RN, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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