The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.
At least 18 years of age at the time of consent.
Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
Written informed consent obtained through the IRB-approved ICF.
Femoral-popliteal vein
Contraindication to systemic or therapeutic doses of anticoagulants.
Contraindication to iodinated contrast that cannot be adequately premedicated.
Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
Patients that are pregnant.
Argon Medical Devices
Lead sponsor
Avania
Collaborator
Medical Metrics Diagnostics, Inc
Collaborator