Study of the Cleaner Vac4 Thrombectomy System for Treating Lower Limb Deep Vein Thrombosis DVT Evaluating Safety and Effectiveness in Patients with Proximal Lower Extremity DVT

What this Trial Is About

Researchers are evaluating the Cleaner Vac4 Thrombectomy System for treating thrombus in patients with lower extremity proximal deep vein thrombosis DVT. This prospective, multi-center, open-label study focuses on assessing the safety, effectiveness, clinical outcomes, device performance, and procedural success in a single DVT cohort. The study is sponsored by Argon Medical Devices and targets adults aged 18 and older with symptomatic DVT confirmed by imaging. Participants will undergo frontline treatment using the Cleaner Vac4 Thrombectomy System, a mechanical aspiration device designed to remove fresh, soft thrombi and emboli from the peripheral venous system. The system includes an aspiration catheter, pump, handpiece, and related components to restore venous blood flow via controlled suction. The study involves one cohort receiving this device-based treatment, followed by scheduled follow-ups at discharge and at 1, 6, 12, and 24 months. During the study, participants will be monitored through clinical assessments and imaging to evaluate technical success at the time of the procedure and adverse events within 30 days. Long-term outcomes assessed include post-thrombotic syndrome severity, venous patency, pain levels, and need for repeat interventions up to 24 months after treatment. Safety and effectiveness data will be collected throughout the study duration, which extends to June 2029.

Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking