Actively Recruiting
A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac4 Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
Led by Argon Medical Devices · Updated on 2026-05-01
185
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Argon Medical Devices
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Cleaner Vac4 Thrombectomy System for treating thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study focuses on clinical outcomes, device performance, and procedural success within a single DVT patient group. The study is sponsored by Argon Medical Devices and aims to provide detailed insights into this treatment approach. Participants will undergo treatment using the Cleaner Vac4 Thrombectomy System, a mechanical device designed to remove fresh, soft clots from peripheral veins through controlled suction. The device includes an aspiration canister with an integrated pump, an 18F aspiration catheter, and related components. After treatment, patients will have follow-up visits at discharge and at 1, 6, 12, and 24 months to monitor their progress and device outcomes. During the study, participants will be assessed for technical success during the initial procedure and monitored for major adverse events within 30 days afterwards. Additional evaluations include serious adverse events related to the device or procedure up to 30 days, severity of post-thrombotic syndrome, venous patency, the need for vessel reintervention, and pain levels over a 24-month period. This comprehensive follow-up allows researchers to gather detailed information about long-term safety and effectiveness.
CONDITIONS
Brief Title
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at the time of consent
- Undergoing frontline treatment with Cleaner Vac4 Thrombectomy System in the peripheral venous vasculature with at least one component introduced into the body
- Provided written informed consent through an IRB-approved form
- Present with unilateral or bilateral lower extremity DVT involving femoral-popliteal vein, common femoral vein, iliac vein, or inferior vena cava
- DVT diagnosis confirmed by imaging within 14 days of the procedure
- Symptomatic DVT with onset within 6 weeks of enrollment
You will not qualify if you...
- Contraindication to systemic or therapeutic doses of anticoagulants
- Contraindication to iodinated contrast that cannot be premedicated
- Life expectancy less than 1 year due to advanced malignancy
- Pregnancy
- Known coagulation disorders or hypercoagulable states that cannot be medically managed
- Treatment of target venous segment with thrombolytics within 14 days prior to procedure
- Known congenital anomalies of inferior vena cava or iliac veins
- History of Patent Foramen Ovale
- Hemoglobin below 8.0 g/dL, INR above 2.0 before warfarin, or platelets below 50,000/�b5l not correctable
- Severe renal impairment (GFR below 30 ml/min) unless on dialysis
- Intermediate-high or high-risk pulmonary embolism
- Complete infrarenal inferior vena cava occlusion
- Chronic non-ambulatory status
- Current enrollment in conflicting investigational device or drug study that may affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At the time of the index procedure
Participants receive treatment with the Cleaner Vac® Thrombectomy System to remove thrombi from the peripheral venous vasculature.
1 procedure visit (in-person)
Duration - Up to 24 months
Participants complete required follow-up visits at discharge and at 1, 6, 12, and 24 months to assess safety, venous patency, and symptom management.
5 visits (in-person) at discharge, 1, 6, 12, and 24 months
Trial Site Locations
Total: 3 locations
1
Baycare Health System
Tampa, Florida, United States, 33607
Actively Recruiting
2
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky, United States, 41017
Actively Recruiting
3
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
Research Team
E
Esther Ajasa, MS
H
Holly Harrison
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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