Actively Recruiting
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Led by Argon Medical Devices · Updated on 2026-05-01
185
Participants Needed
3
Research Sites
173 weeks
Total Duration
On this page
Sponsors
A
Argon Medical Devices
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.
CONDITIONS
Official 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 old at the time of consent
- Undergoing primary treatment with the Cleaner Vac4 Thrombectomy System in peripheral veins with device component inserted
- Provide written informed consent
- Have 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 before procedure
- Symptomatic DVT with symptom onset within 6 weeks before enrollment
You will not qualify if you...
- Contraindication to systemic or therapeutic anticoagulants
- Contraindication to iodinated contrast that cannot be premedicated
- Life expectancy less than 1 year due to advanced cancer
- Pregnant women
- Known coagulation disorders or thrombophilia that cannot be medically managed
- Thrombolytic treatment in target vein segment within 14 days before procedure
- Known congenital anomalies of inferior vena cava or iliac veins
- History of Patent Foramen Ovale (PFO)
- Hemoglobin less than 8.0 g/dL, INR over 2.0 before warfarin, or platelets under 50,000/µl that cannot be corrected
- Severe kidney impairment with GFR under 30 ml/min if not on dialysis
- Intermediate-high or high-risk pulmonary embolism
- Complete infrarenal inferior vena cava occlusion
- Chronic non-ambulatory status
- Currently enrolled in another investigational drug or device study that may affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
H
Holly Harrison
CONTACT
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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