A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
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.
∙ Participants must meet all the following criteria to be eligible for the study:
• 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.
• For the DVT cohort, participants must meet all criteria above and below to be eligible for the study:
• Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins:
‣ Femoral-popliteal vein
⁃ Common femoral vein
⁃ Iliac vein
⁃ Inferior Vena Cava (IVC)
• DVT diagnosis confirmed by imaging within 14 days of the index procedure.
• Symptomatic DVT with onset within 6 weeks of enrollment.