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Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Sponsor: Argon Medical Devices
Summary
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.
Official title: A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
185
Start Date
2026-02-04
Completion Date
2029-06
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
Aspiration thrombectomy system
The Cleaner Vac® Thrombectomy System is a percutaneous mechanical aspiration thrombectomy device designed for the removal of fresh, soft thrombi and emboli from the peripheral venous vasculature. The system includes an aspiration canister with integrated pump, an 18F aspiration catheter, a handpiece with aspiration control lever, a dilator, and an optional flushing adapter. The device operates via controlled suction to extract thrombus and restore venous patency.
Locations (3)
Baycare Health System
Tampa, Florida, United States
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States