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.