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

Launched by ARGON MEDICAL DEVICES · Jul 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how safe and effective a device called the Cleaner Vac Thrombectomy System is for removing blood clots from veins outside the heart, especially in the legs. Blood clots in these veins can cause serious problems, like deep vein thrombosis (DVT), which is when clots form in the large veins of the lower leg or thigh. The study will follow patients who receive treatment with this device to see how well it works and how safe it is in a wide range of real-life patients.

People who may be eligible are adults aged 18 or older who have blood clots in their leg veins and are getting the Cleaner Vac device as their first treatment for these clots. To join, their DVT must be confirmed by imaging tests within two weeks before the procedure, and their symptoms should have started within six weeks. The study will not include patients with certain health issues, like severe kidney problems, serious bleeding risks, or pregnancy. Participants can expect to have their clot treated using the Cleaner Vac device and then be followed over time to check how well the treatment worked and if there are any side effects. This study aims to help doctors understand if this device is a good option for treating blood clots in veins in everyday medical practice.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• For the Registry cohort, 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:
• For the Registry cohort, subjects will be excluded from the study if any of the following criteria are met:
• • 1. Contraindication to systemic or therapeutic doses of anticoagulants.
• • 2. Contraindication to iodinated contrast that cannot be adequately premedicated.
• • 3. Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
• • 4. Patients that are pregnant.
• • 5. 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.
• For the DVT cohort, subjects will be excluded from the study if any of the above or below criteria are met:
• • 6. Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
• • 7. Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
• • 8. Known history of a Patent Foramen Ovale (PFO).
• • 9. Hemoglobin \< 8.0 g/dL, INR \> 2.0 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment.
• • 10. 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.
• 11. Patients with intermediate-high risk or high-risk pulmonary embolism (PE) defined as follows:
• • 1. 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)
• • 2. Intermediate-high-risk PE: Hemodynamically stable patients with both right ventricular (RV) dysfunction (on echocardiography or CT) and elevated cardiac biomarkers (e.g., troponin)..
• • 12. Complete infrarenal IVC occlusion.
• • 13. Chronic non-ambulatory status.
• • 14. 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.