Using a new device to treat aortic aneurysms

Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study

This study is testing a new device to see if it can safely treat aortic aneurysms near the kidney arteries in patients who can't have standard surgeries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Missouri-Columbia (other)
• Locations: 1 site (Columbia, Missouri)
• Trial ID: NCT06411990 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the LIFE device in treating aortic aneurysms located near the kidney arteries. Participants will receive treatment with the LIFE device, which is designed to cover tears or leaks in the aorta while allowing blood flow to vital branches. The study will monitor participants over a period of five years, assessing their health through pulse checks, blood tests, and CT scans to evaluate the aneurysm. The trial specifically targets patients who are not candidates for traditional endovascular or open repair methods.

Who should consider this trial

Good fit: Ideal candidates include individuals with juxtarenal or pararenal aortic aneurysms greater than 5.5 cm in men or 5.0 cm in women, who are not suitable for standard repair methods.

Not a fit: Patients with smaller aneurysms or those who are candidates for traditional endovascular or open repair methods may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with complex aortic aneurysms who currently have limited alternatives.

How similar studies have performed: While the LIFE device represents a novel approach, similar studies in fenestrated endovascular repair have shown promising results in treating complex aortic aneurysms.

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.

Where this trial is running

Columbia, Missouri

• University of Missouri - Columbia — Columbia, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Jonathan Bath, MD — University of Missouri School - Columbia
• Study coordinator: Jennifer Randolph, Nurse, Clinical Research, RN, BSN

Conditions: Aortic Aneurysm, Endovascular Aneurysm Repair, Fenestrated Endovascular Aneurysm Repair