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  • Clinical evidence

    • Program overview

    Purpose

    The VenaSeal™ Spectrum Program is the largest post-market clinical study of the VenaSeal™ closure system compared to the current standards of care.

    The VenaSeal™ Spectrum Program is:

    • Comprised of three distinct studies
    • Designed to expand evidence across the spectrum of superficial venous disease
    • Designed with novel, patient-centered endpoints

    Design

    • The outcomes of the VenaSeal™ treatments are compared to either endothermal ablation (ETA) or surgical stripping (SS) in two randomized controlled studies for the CEAP 2–5 population.
    • The outcomes of the VenaSeal™ treatment are prospectively assessed in the treatment of active venous leg ulcer (VLU) patients in a separate single-arm study for the CEAP 6 population. 

    Primary endpoints

    Venous treatment satisfaction questionnaire (TSQ)

    Description

    • Patient-centered primary endpoint in the VenaSeal™ Spectrum SS study and the VenaSeal™ Spectrum ETA study
    • Measures patient  treatment satisfaction
    • Compares patient treatment satisfaction around the peri-procedural timepoint when treated with the VenaSeal™ closure system to other modalities such as endothermal ablation (ETA) or surgical stripping (SS)
    • Assesses patient treatment satisfaction of venous leg ulcer (VLU) patients when treated with the VenaSeal™ closure system in the VenaSeal™ Spectrum VLU study

    Purpose

    VenousTSQ is structured to capture patient satisfaction with vein treatment.

    • New patient-reported outcome measure
    • Created to measure treatment satisfaction following superficial venous disease treatment
    • Designed to assess peri-procedural and longer-term patient treatment satisfaction measures identified by patients as important for treatment satisfaction/dissatisfaction

    Measurement

    VenousTSQ — Early
    Peri-procedural patient treatment satisfaction measure Measured at 30 days post-procedure

     

    VenousTSQ — Status
    Patient treatment satisfaction measure for longer-term follow-up Measured at 30 days, 6 months, and 12 months post-procedure

    Elimination of truncal reflux

    Description

    • Patient-centered primary endpoint in the VenaSeal™ Spectrum SS study and the VenaSeal™ Spectrum ETA study
    • Calculated by the percentage of target vein length successfully treated
    • Measured in each target vein at the time of index procedure

    Purpose

    A more comprehensive approach for addressing patient symptoms.

    • Captures the treated vein lengths as a percentage of the diseased vein (how much of the disease was actually treated)
    • Expands the definition of technical success to account for potential residual reflux outside of the treated segment

    Measurement

    • Calculated as the percentage of diseased vein treated at index procedure
    • Actual treatment length ÷ length of diseased vein = % of treated vein

    Time to ulcer healing

    Description

    • Primary endpoint in the VenaSeal™ Spectrum VLU study
    • Patients enrolled in the venous leg ulcer (VLU) study have CEAP 6 disease or active leg ulcers and are treated with the VenaSeal™ closure system
    • Time to ulcer healing will be measured for each patient in follow-up visits 
       

    Purpose

    • While a correlation between venous interventions and leg ulcer healing is evident in the clinical literature, there is limited clinical evidence that exists regarding time to ulcer healing following the VenaSeal™ treatment. 

    Measurement

    • In addition to the regular follow-up visits until 60 months, CEAP 6 will also have follow-up visits at 2, 3, 4, 5, 8, and 10 months until healing verification.

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