Cleaner Long-tErm Assessment Registry – Venous Insights and Efficacy With eXtended Tracking (CLEAR-VIEW XT)

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).

•  A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
• Up to 185 participants diagnosed with lower extremity proximal deep vein thrombosis (DVT) and treated with the Cleaner Vac® (CVAC) Thrombectomy System.

• The primary effectiveness endpoint is successful completion of the thrombectomy procedure with ≥75% thrombus removal in the target venous segment (measured by Marder score & determined by core imaging lab)
• The primary safety endpoint is a composite of the following Major Adverse Events (MAEs) through 30 days:
  • All-cause mortality
  • Symptomatic PE
  • Major Bleeding (per ISTH criteria)
  • Re-occlusion of the TVS
  • Device-related serious adverse events (SAEs)

• DVT cohort: Subjects will be followed for 24 months from index procedure

Key Inclusion Criteria

• • Adults ages ≥ 18 years of age that undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
  • Present with unilateral or bilateral lower extremity DVT involving one or more vein(s):
    • Femoral-popliteal
    • Common femoral vein
    • Iliac vein
    • Inferior vena cava (IVC)
  • DVT diagnosis confirmed by imaging within 14 days of the index procedure
  • Symptomatic DVT with onset within 6 weeks of enrollment.

Key Exclusion Criteria

• • Contraindication to systemic or therapeutic doses of anticoagulants
  • Uncontrolled clotting disorders (genetic & acquired) that, as per PI opinion, cannot be safely managed during the study
  • Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
  • Complete infrarenal IVC occlusion
  • Current enrollment in another investigational device or drug study that may confound the results of this study