Angiodynamics, Inc.
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.
Up to 1500 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.
Inclusion Criteria: * Age of subject is ≥ 18. * Estimated life expectancy ≥1 year. * Subject is able and willing to comply with all assessments in the study. * Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. * Rutherford Category classification of 4 or 5 of the target limb. * Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines. Angiographic Inclusion Criteria * Target lesion that is located in a native, de novo infra-popliteal artery…
Auryon Atherectomy System is composed of a laser and catheter
Balloon Angioplasty alone