A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceAspiration 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 SystemTampa, Florida
- St. Elizabeth Healthcare - EdgewoodEdgewood, Kentucky
- Baylor Scott & White The Heart Hospital - PlanoPlano, Texas