Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking

Inclusion criteria

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.

Exclusion criteria

Subjects will be excluded from the study if any of the following criteria are met:

• 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.
• Known coagulation disorders both acquired (Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period.
• Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
• Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
• Known history of a Patent Foramen Ovale (PFO).
• Hemoglobin < 8.0 g/dL, INR > 2.0 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment.
• Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis. Patients with GFR <30 ml/min who are already on dialysis can be enrolled.
• Patients with intermediate-high risk or high-risk pulmonary embolism (PE) defined as follows:

• High-risk PE: Presence of hemodynamic instability, including cardiac arrest, obstructive shock (systolic blood pressure <90 mmHg or need for vasopressors with signs of end-organ hypoperfusion), or persistent hypotension (systolic BP <90 mmHg or a drop ≥40 mmHg for >15 minutes not due to other causes)
• Intermediate-high-risk PE: Hemodynamically stable patients with both right ventricular (RV) dysfunction (on echocardiography or CT) and elevated cardiac biomarkers (e.g., troponin).
• Complete infrarenal IVC occlusion.
• Chronic non-ambulatory status.
• Current enrollment in another investigational device or drug study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.