Leominster

Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in the arteries of their legs due to peripheral artery disease (PAD). The study aims to determine whether the Thor system is safe and effective in treating these lesions. Patients often experience leg pain during walking or rest caused by reduced blood flow, and this trial focuses on treating these specific types of arterial blockages. Participants will receive treatment using the Thor laser atherectomy system, which involves using laser energy to remove calcified plaque and modify calcium in the affected leg arteries. The procedure includes x-ray imaging of the leg arteries, and doctors may also use additional treatments such as angioplasty balloons, drug-coated balloons, stents, or clot filters if needed. There is no comparison group in this study, so all participants undergo the treatment with the Thor system. Participants will have a screening visit before the procedure, including medical history review, physical exams, blood flow tests, blood tests, and pregnancy testing if applicable. After treatment, patients will be monitored until discharge or up to 24 hours if they remain hospitalized. Follow-up visits will occur at 30 days, 6 months, and 12 months after treatment to assess medical status, leg blood flow via tests and ultrasound, walking ability, quality of life, and any adverse events. The total participation time is about one year, with enrollment expected to take up to two years across multiple U.S. sites.