Cleaner Vac long-term registry of venous thrombectomy outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Janna, LLC
  Fort Lauderdale, Florida, United States Recruiting
• Indiana University Health
  Indianapolis, Indiana, 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
• Email: clinical@argonmedical.com
• Phone: 469-423-2280

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.