Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe
brief summary
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.
detailed description
Up to 500 subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for, and be enrolled in, the observational study.
official title
Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia