Actively Recruiting
Laser In Situ Fenestration Study
Led by Jonathan Bath · Updated on 2025-03-28
15
Participants Needed
1
Research Sites
345 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
The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are: * If the LIFE device works to treat aortic aneurysms * What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.
CONDITIONS
Official Title
Laser In Situ Fenestration Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aortic aneurysm >5.5 cm in men or >5.0 cm in women, or rapid expansion with high rupture risk in the juxtarenal or pararenal aorta
- Requires endovascular aortic repair covering renovisceral branches
- Not a candidate or high risk for open repair due to conditions like renal dysfunction, previous surgeries, obesity, cardiac risk, COPD, diabetes, smoking, or use of blood thinners
- Proximal aortic landing zone in Zone 5 or previous graft at least 10 mm long and 20-40 mm in diameter
- At least 5 mm distance between graft fabric top and renovisceral branch orifice
- Iliofemoral artery at least 5 mm and axillary brachial artery sufficient for device insertion
- Renovisceral artery diameter between 4 and 13 mm at origin
- Anatomy suitable for complete aneurysm exclusion with 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
- Patient or legal representative consents and agrees to HIPAA authorization
- Able and willing to meet all study and follow-up requirements
You will not qualify if you...
- Known allergies to device materials such as Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, or heparin
- Hypersensitivity or contraindication to anticoagulation or contrast media that cannot be medically managed
- Uncorrectable blood clotting disorders
- Body size or shape that prevents clear imaging of the aorta or exceeds equipment limits
- Participation in another experimental therapy research protocol
- Judged unsuitable for study participation by the investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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