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.
The study will enroll up to 185 adult participants undergoing percutaneous mechanical thrombectomy using the Cleaner Vac® Thrombectomy System for the treatment of thrombus in the peripheral venous vasculature. Participants must be at least 18 years old and undergoing frontline treatment with the Cleaner Vac® device. The DVT subgroup must have symptomatic, imaging-confirmed DVT involving the femoral-popliteal, common femoral, iliac veins, or inferior vena cava (IVC), with symptom onset within 6 weeks and imaging confirmation within 14 days of the index procedure. The study population is intended to reflect a real-world, all-comers cohort treated across up to 50 investigational sites in the United States.
Cohort
Prospective
Aspiration thrombectomy system
DeviceThe Cleaner Vac® Thrombectomy System is a percutaneous mechanical aspiration thrombectomy device designed for the removal of fresh, soft thrombi and emboli from the peripheral venous vasculature. The system includes an aspiration canister with integrated pump, an 18F aspiration catheter, a handpiece with aspiration control lever, a dilator, and an optional flushing adapter. The device operates via controlled suction to extract thrombus and restore venous patency.
Technical Success
≥75% thrombus removal in the target venous segment, assessed by change in Marder Score
Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure
Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs)
Post-Thrombotic Syndrome Severity
Assessment of post-thrombotic syndrome using the Villalta score, which combines patient-reported symptoms and clinician-assessed signs to generate a composite score. A score ≥5 indicates the presence of post-thrombotic syndrome, with higher scores reflecting greater severity.
Venous patency
Presence of flow in the treated venous segment without re-thrombosis
Need for Target Vessel Reintervention
Any additional endovascular or surgical procedure to address recurrent/residual thrombus
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