Study of the LIFE Device for Treating Aortic Aneurysms Near Kidney Arteries Using Endovascular Repair

What this Trial Is About

This research aims to evaluate a new device called the LIFE device for treating aneurysms in the aorta, which is the large blood vessel carrying blood from the heart to the body. The study focuses on people with aneurysms near the kidney arteries, known as juxtarenal or pararenal aortic aneurysms, who are not eligible for currently approved endovascular or open repairs. It investigates whether the LIFE device works for these aneurysms and what medical issues may occur during its use. Participants will receive treatment using the LIFE device, which is placed endovascularly through blood vessels in the groin. The device covers the aneurysm tear or leak and includes side branches that allow blood flow to important arteries for the kidneys, spleen, intestines, or liver. This trial enrolls patients who cannot use other approved devices and are unwilling or unable to travel to sites with manufacturer-made devices. The treatment is a fenestrated endovascular aneurysm repair using the LIFE device system. After treatment, participants will have follow-up visits at 30 days, 6 months, 1 year, and annually up to 5 years. During these visits, pulses will be checked, blood tests will assess kidney function, and CT scans will monitor the aneurysm area. The study measures include freedom from death and major adverse events within 30 days, technical success of the device procedure, and absence of complications such as leaks or device migration up to 12 months. Long-term monitoring continues for up to 5 years to evaluate device performance and safety.

Laser In Situ Fenestration Study