Objective

 

Assess the safety and effectiveness of the ClotTriever System in the treatment of acute and chronic lower extremity Venous clot.

Design

 

  • Assess the safety and effectiveness of the ClotTriever System in the treatment of acute and chronic lower extremity Venous clot.

Key Inclusion Criteria

    • Age ≥ 18 all comers, excluding patients with IVC filter or stent
    Z

    Primary Objectives

      • Technical success: complete or near-complete (≥75% removal of thrombus from the treated vein segments via Marder score with venography)
      • Composite MAE at 30 days: all-cause mortality, major bleeding, PE, re-thrombosis of treated vein segment(s)

      Study Size

        • Up to 500 patients total
        • Primary Analytic Arm: 91 pts with unilateral acute and chronic DVT (clot age ≤ 6 weeks) followed 30 days
        • Registry Arm: Up to 409 patients followed 2 yrs. All comer arm including patients with bilateral disease and clot age ≥ 6 weeks

        CLOUT Highlights

        CLOUT Interim Analysis 250 Patient, 6-Month Follow-Up Data
        Presented at NCVH June 2021

        THE PURSUIT OF

        LYTIC-FREE, SINGLE-SESSION, BLOODLESS THROMBECTOMY

        99.6%

        Single Session Treatment

        50.0mL

        Median Estimated Blood Loss

        0mg

        Thrombolytics Used

        100%

        Clot removal in the majority of patients

        via core lab-adjudicated Marder scores

        DEMONSTRATED SAFETY

        30-Day Safety Outcomes

        Vessel / Valve Damage

        0.0%

        Acute Renal Injury

        0.0%

        Device Related SAEs

        0.4%

        Vessel / Valve Damage

        Acute Renal Injury

        Device Related SAEs

        0.0%

        0.0%

        0.4%

        LIFE WITHOUT CLOT

        6 Month Outcomes

        Normal flow via duplex ultrasound

        89.7%

        Freedom from moderate or severe PTS

        92.2%

        Reduction in pain

        (NPRS median score)

        100%

        89.7%

        92.2%

        100%

        Normal flow via duplex ultrasound

        Freedom from moderate or severe PTS

        Reduction in pain

        (NPRS median score)

        Conclusions

        Initial CLOUT data demonstrates the ability of ClotTriever to successfully treat a range of clot chronicity in real world DVT patients in a single session, without the need for thrombolytic drugs.