Clinical trial NCT06411990: Laser In Situ Fenestration Study
Official title: Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Aneurysm
Endovascular Aneurysm Repair
Keywords: Fenestrated Endovascular Aneurysm Repair
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
First posted: 2024-05-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single arm clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In this clinical trial the LIFE device is used to treat people with aneurysms in the aorta near the kidney arteries (called juxtarenal or pararenal aortic aneurysms). Tubes, called stent grafts, are typically inserted through blood vessels in the groin and placed inside the aorta in the abdomen and chest area (endovascularly placed) to cover the tear or leak in the aorta. The LIFE device covers the tear or leak and has side branches to let blood flow into the kidney, spleen, intestine, or liver arteries. Participants in this study are not candidates for endovascular devices approved for endovascular aorta repair to the juxtarenal or pararenal aorta, not candidates for open repair, not willing to travel to sites that have access to manufacturer-made endovascular devices, and patients for whom there are no favorable alternatives, for example, urgent, symptomatic, and emergency cases.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Endovascular aortic repair requiring coverage of renovisceral branches.
3. 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.
4. 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.
5. Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.
6. At least a 5 mm iliofemoral artery to accept the endovascular stent graft device and an axillary brachial artery of sufficient diameter to accept the laser catheter.
7. Renovisceral diameter between 4 and 13 mm at the origin.
8. At the time of case planning, the patient's anatomy appears amenable to complete exclusion of the aneurysm with laser fenestration techniques.
9. Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices.
10. Not a candidate for currently approved endovascular options.
11. 18 years or older.
12. Patient or legally authorized representative agrees to participate in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
13. Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits.

Exclusion Criteria:

1. Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.
2. Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
3. Uncorrectable coagulopathy.
4. Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.
5. Concurrent participation in another research protocol for investigation of an experimental therapy.
6. Subject has been judged to be unsuitable for participation in the study by the Investigator for any reason.

Primary outcomes:
measure: Number of participants with freedom from death and major adverse events (MAE)
timeFrame: 30 days
measure: Number of participants with device procedure technical success and freedom from endoleak, migration, aortic enlargement, aortic rupture, and aortic or branch-related reinterventions in
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with delivery and deployment of the LIFE Device System
timeFrame: Procedure
measure: Number of participants with delivery and deployment of the thoracic/abdominal stent graft
timeFrame: Procedure
measure: Number of participants with coverage of intended aneurysm
timeFrame: Procedure
measure: Number of participants with contrast flow into target renovisceral vessels
timeFrame: Procedure
measure: Estimated blood loss
timeFrame: Procedure
measure: Ventilator days
timeFrame: From Procedure until the date of Hospital Discharge, typically 1-2 days
measure: Days to oral intake
timeFrame: From Procedure until the date of Hospital Discharge, typically 1-2 days
measure: Intensive Care Unit (ICU) days
timeFrame: From Procedure until the date of Hospital Discharge, typically 1-2 days
measure: Days to hospital discharge
timeFrame: From Procedure until the date of Hospital Discharge, typically 1-2 days
measure: Procedure time
timeFrame: Procedure
measure: Fluoroscopy time
timeFrame: Procedure
measure: Endoleak rate
timeFrame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
measure: Number of participants with device integrity failure
timeFrame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
measure: Number of participants with branch vessel device events
timeFrame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
measure: Number of participants with aortic growth
timeFrame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
measure: Number of participants with unplanned secondary procedures
timeFrame: 5 Years
measure: Number of participants with device migration
timeFrame: 6 Months, and 1, 2, 3, 4, and 5 Years
measure: All adverse events
timeFrame: 5 Years
measure: Freedom from aneurysm-related mortality
timeFrame: 30 Days, 6 Months, and 1, 2, 3, 4, and 5 Years
measure: Freedom from all-cause mortality
timeFrame: 6 Months and 1, 2, 3, 4, and 5 Years
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
Study officials:
affiliation: University of Missouri School - Columbia
name: Jonathan Bath, MD
role: PRINCIPAL_INVESTIGATOR
References: