Study of the Thor Laser Atherectomy System to Treat Blockages in Leg Arteries Caused by Peripheral Artery Disease in Adults

What this Trial Is About

Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in leg arteries caused by peripheral artery disease PAD. The study aims to determine whether the Thor system is safe and effective for treating these lesions. Patients experience leg pain due to poor blood flow, and the study will observe how the Thor system works in this setting. All participants will receive treatment using the Thor laser atherectomy system, which targets calcified lesions to improve blood flow. During the procedure, doctors may also use additional devices such as angioplasty balloons, drug-coated balloons, stents, and clot-collecting filters if needed. The procedure includes x-ray imaging, and patients will be monitored closely until discharge or for up to 24 hours after treatment. Participants will have follow-up visits at discharge, 30 days, 6 months, and 12 months after the procedure. These visits include medical history reviews, physical exams of the legs, blood flow tests using arm and leg blood pressure comparisons, ultrasound imaging, and questionnaires about walking ability and quality of life. The study will measure outcomes such as freedom from major adverse events, procedural success, lesion openness, and improvements in walking and health surveys over one year.

The THOR IDE Study