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 thrombosis in the peripheral venous vasculature including a subgroup with lower extremity proximal deep vein thrombosis (DVT)

• A prospective, multi-center, open-label clinical investigation and longitudinal registry including a subgroup of DVT patients
• Up to 500 adult subjects in the peripheral venous vasculature, including a DVT subgroup of 185 subjects

• 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 6 months from index procedure; may opt into registry
• Registry cohort: Subject will be followed for 2 years from index procedure

Key Inclusion Criteria

• Registry cohort:
  • Adults ages ≥ 18 years of age that undergo aspiration thrombectomy of peripheral venous vasculature (index procedure) using Cleaner Vac® Thrombectomy System
• DVT cohort:
  • Must meet criteria for Registry cohort
  • 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

• Registry cohort
  • Contraindication to systemic or therapeutic doses of anticoagulants
  • Uncontrolled clotting disorders (genetic & acquired) that cannot be safely managed during the study
• DVT cohort
  • Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure

Complete infrarenal IVC occlusion