Cleaner Vac long-term registry of venous thrombectomy outcomes

A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)

This project tests whether the Cleaner Vac® thrombectomy system can safely and effectively remove clots in adults with proximal lower‑extremity deep vein thrombosis (DVT).

Quick facts

• Study type: Observational
• Enrollment: 185 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Argon Medical Devices (Industry-sponsored)
• Locations: 3 sites (Tampa, Florida and 2 other locations)
• Trial ID: NCT07102160 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, open-label registry that follows adults treated with the Cleaner Vac® Aspiration Thrombectomy System as frontline therapy for proximal lower‑extremity DVT. The single DVT cohort includes patients with symptomatic unilateral or bilateral DVT involving femoral‑popliteal, common femoral, iliac veins, or the inferior vena cava, with diagnosis confirmed by imaging within 14 days and symptom onset within six weeks. The study collects procedural success metrics, device performance data, and clinical safety and effectiveness outcomes at participating centers. Data will be used to characterize real-world device performance and patient outcomes after percutaneous mechanical thrombectomy with Cleaner Vac.

Who should consider this trial

Good fit: Adults (18+) with symptomatic proximal lower‑extremity DVT confirmed by imaging within 14 days, symptom onset within six weeks, who receive the Cleaner Vac® system as frontline treatment and provide informed consent are ideal candidates.

Not a fit: Patients who do not receive Cleaner Vac as their primary treatment, who lack recent imaging or eligible symptom timing, or who have contraindications to thrombectomy or systemic therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could offer a minimally invasive option to restore venous flow, reduce leg symptoms, and lower the risk of DVT‑related complications.

How similar studies have performed: Percutaneous mechanical and aspiration thrombectomy approaches have shown promise in prior registries and case series, but robust, long‑term multi‑center data specifically for Cleaner Vac are limited.

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 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.
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.

Where this trial is running

Tampa, Florida and 2 other locations

• Baycare Health System — Tampa, Florida, United States (Recruiting)
• St. Elizabeth Healthcare - Edgewood — Edgewood, Kentucky, United States (Recruiting)
• Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Esther Ajasa, MS

Conditions Deep Vein Thrombosis; Thrombus in the Peripheral Venous Vasculature; Venous Embolism; Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts; Aspiration Thrombectomy; Peripheral VTE; Venous thromboembolism; Percutaneous mechanical thrombectomy