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.
Study Type
OBSERVATIONAL
Enrollment
185
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.
Baycare Health System
Tampa, Florida, United States
RECRUITINGSt. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky, United States
RECRUITINGBaylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States
RECRUITINGTechnical Success
≥75% thrombus removal in the target venous segment, assessed by change in Marder Score
Time frame: At the time of the index procedure
Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure
Time frame: 30 days post-index procedure
Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs)
Time frame: 30 days post-procedure
Post-Thrombotic Syndrome Severity
Assessment of post-thrombotic syndrome using the Villalta score, which combines patient-reported symptoms and clinician-assessed signs to generate a composite score. A score ≥5 indicates the presence of post-thrombotic syndrome, with higher scores reflecting greater severity.
Time frame: Up to 24 months
Venous patency
Presence of flow in the treated venous segment without re-thrombosis
Time frame: From 30 days post-treatment to the end of the study period
Need for Target Vessel Reintervention
Any additional endovascular or surgical procedure to address recurrent/residual thrombus
Time frame: From date of index procedure up to 24 months
Numeric Pain Rating Scale
Self-reported health status measured using the Numeric Pain Rating Scale questionnaire, which evaluates current, best, and worst pain experienced on a 0 (minimum) to 10 (maximum) level scale. 10 having worst pain imaginable.
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.