Laser In Situ Fenestration Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonathan Bath
About this trial
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.
Eligibility criteria
Qualifiers
Aortic aneurysm >5.5 cm in a man or > 5.0 cm in a woman or rapid expansion deemed at significant risk for rupture in the juxtarenal or pararenal aorta.
Endovascular aortic repair requiring coverage of renovisceral branches.
Not candidate or at high risk for open repair. For example, but not exclusively, due to renal dysfunction, previous abdominal surgery, obese body habitus, previous coronary bypass grafts or high cardiac risk, chronic obstructive pulmonary disease (COPD) or on oxygen at rest, poorly controlled diabetes, current smoking, or antiplatelet or anticoagulation use.
Proximal aortic landing zone in Zone 5 of the aorta or previous graft of at least 10 mm in length and diameter of between 20 and 40 mm.
Disqualifiers
Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.
Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
Uncorrectable coagulopathy.
Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.
Trial design
Treatments tested in this trial
- Fenestrated Endovascular Aneurysm Repair using the LIFE Device System
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Jonathan Bath
Lead sponsor
University of Missouri-Columbia
Sponsor institution
University of Missouri-Columbia
Collaborator
Source ClinicalTrials.gov