Study Comparing Auryon Atherectomy System Plus Balloon Angioplasty to Balloon Angioplasty Alone for Treating Lower Leg Artery Blockages in Critical Limb Ischemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Auryon Atherectomy System combined with balloon angioplasty compared to balloon angioplasty alone in treating blockages in the lower limbs, specifically in patients with critical limb ischemia. The study aims to determine if using the Auryon system improves outcomes such as reducing death, amputation, and the need for additional procedures while maintaining blood vessel openness. Participants will be randomly assigned to one of two groups one group will receive treatment with the Auryon Atherectomy System followed by balloon angioplasty, while the other group will receive balloon angioplasty alone. The Auryon system includes a laser and catheter device. The trial includes an observational study for patients who do not meet the criteria for randomization but are treated with the Auryon system. Treatments and follow-up extend up to 24 months after the procedure. Throughout the study, participants will undergo various assessments including imaging tests like duplex ultrasound at hospital discharge, and at 30 days, 6, 12, and 24 months. Researchers will measure clinical improvements, limb amputation rates, blood flow indexes, wound healing, quality of life, and major adverse limb and cardiovascular events. The primary outcome compares groups on a combined set of measures at 12 months. Safety and device success are also monitored during and after the procedures.

Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone