Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
This study tests the safety and effectiveness of the Cleaner Vac® Thrombectomy System, a device designed to remove blood clots from veins in the lower legs. Researchers will track patients over a long period to see how well this treatment works and if it is safe for people with deep vein thrombosis.
Key Objective: The trial evaluates whether the Cleaner Vac® device can safely and effectively remove blood clots from leg veins to improve patient outcomes.
Who to Consider: Patients with deep vein thrombosis (blood clots) in the lower extremity proximal veins who are seeking minimally invasive treatment options should consider enrolling.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Participants must meet all the following criteria to be eligible for the study: 1. At least 18 years of age at the time of consent. 2. Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body. 3. Written informed consent obtained through the IRB-approved ICF. For the DVT cohort, participants must meet all criteria above and below to be eligible for the study: 4. Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins: 1. Femoral-popliteal vein 2. Common femoral vein 3. Iliac vein 4. Inferior Vena Cava (IVC) 5. DVT diagnosis confirmed by imaging within 14 days of the index procedure. 6. Symptomatic DVT with onset within 6 weeks of enrollment. Exclusion Criteria: Subjects will be excluded from the study if any of the following criteria are met: 1. Contraindication to systemic or therapeutic doses of anticoagula