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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Fenestrated Endovascular Aneurysm Repair using the LIFE Device System
DeviceFenestrated Endovascular Aneurysm Repair
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Endovascular Aneurysm RepairExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with freedom from death and major adverse events (MAE)
Number of subjects with freedom from all cause mortality and freedom from major adverse events. Major adverse events include myocardial infarction, chronic renal insufficiency / chronic renal failure requiring, dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilatory support.
Time frame
30 days2
Number of participants with device procedure technical success and freedom from endoleak, migration, aortic enlargement, aortic rupture, and aortic or branch-related reinterventions in
Device technical success (at the end of index procedure) and freedom from Type I and III endoleak, device migration ≥ 10 mm, aortic enlargement ≥ 5 mm, aortic rupture, and aortic or branch-related reinterventions, including conversion to open repair (within 12 months of the index procedure)
Time frame
12 monthsSecondary outcomes
1
Number of participants with delivery and deployment of the LIFE Device System
Ability to deliver and deploy the LIFE Device System
Time frame
Procedure2
Number of participants with delivery and deployment of the thoracic/abdominal stent graft
Ability to deliver and deploy the thoracic/abdominal stent graft
Time frame
Procedure3
Number of participants with coverage of intended aneurysm
Ability to cover the intended aneurysm
Time frame
Procedure4
Number of participants with contrast flow into target renovisceral vessels
Contrast flow into the target renovisceral vessels
Time frame
ProcedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jonathan Bath
Lead sponsor
University of Missouri-Columbia
Sponsor institution
University of Missouri-Columbia
Collaborator
Source ClinicalTrials.gov