Study of the FastWire System for Treating Chronic Total Occlusion in Lower Limb Arteries Evaluating Safety and Effectiveness in Patients Aged 18 to 85

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the FastWire System in patients with chronic total occlusions CTOs in the peripheral arteries causing ischemic limbs. It is a single-arm, multi-center, pivotal study involving up to 65 participants who meet specific inclusion and exclusion criteria. The study focuses on assessing whether the FastWire System can assist in placing guidewires or treatment devices beyond these arterial blockages. Participants will undergo a procedure using the FastWire System device to cross CTO caps and multiple lesions in their peripheral arteries. The study does not involve comparison groups and monitors clinical and technical success on the day of the procedure, along with safety events up to 30 days afterward. The device is used intra-luminally during the procedure to facilitate revascularization of lower limbs. During the study, participants will be closely monitored for clinical success and freedom from serious adverse events on the procedure day and up to 30 days post-procedure. Researchers will evaluate technical and procedural success, vessel dissection or bleeding within 24 to 36 hours, and any procedure-related mortality up to 30 days. The total study involvement lasts through the initial procedure and a 30-day follow-up period to assess safety and efficacy outcomes.

FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW