Evaluation of the Artix Thrombectomy System for Treating Acute Lower Limb Arterial Blockages

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Artix Thrombectomy System in patients who have acute blockages in the arteries of the lower limbs. This post-market, prospective, multicenter, single-arm study focuses on treating acute lower limb arterial occlusion in adults aged 18 years and older. The study aims to better understand the outcomes of using this device to remove arterial clots. Participants will receive treatment using the Artix Thrombectomy System, a device designed to remove emboli and thrombi from the lower extremity arteries without surgery. The treatment targets native vessels with occlusions below the inguinal ligament and vessel sizes between 3 mm and 8 mm. The study observes patients immediately after the procedure and follows them for up to one month to assess safety and effectiveness outcomes. During the study, participants will be monitored for immediate procedure success and safety within 48 hours. Follow-up assessments at one month will include evaluations of mortality, limb salvage, and amputation-free survival. Researchers will collect data on adverse events like distal embolization and overall survival. Throughout the study, patients will undergo clinical assessments and safety monitoring to track their progress and responses to the treatment.

The ArtixASCEND Study