European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

Study Overview
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Brief Summary
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The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins GSV in a routine clinical setting.

Detailed Description
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This is a post market, observational study of closure of the great saphenous vein GSV. Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.

Official Title
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Post Market Study - European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study

Conditions
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Venous Insufficiency of Leg

Intervention / Treatment
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* Device: CE Marked Sapheon Closure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and ≤ 70 years of age. Symptomatic primary Great Saphenous Vein GSV incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging. CEAP classification of C2, C3 or C4. Ability to walk unassisted. Ability to attend follow-up visits. Ability to understand the requirements of the study and to provide written informed consent. GSV on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter). Exclusion Criteria: Life expectancy < 1 year. Regular pain medication. Anticoagulation including Heparin or Coumadin. Previous Deep Vein Thrombosis DVT. Previous superficial thrombophlebitis in GSV. Previous venous treatment on target limb. Known Hyper-coagulable disorder. Conditions which prevent routine vein treatment like: Acute disease, Immobilization or inability to ambulate, and Pregnancy. Tortuous GSV, which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed). Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein. Known sensitivity to the cyanoacrylate CA adhesive. Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CE Marked Sapheon Closure System in GSV<br>CE Marked Sapheon Closure System in closure of incompetent great saphenous veins GSV in a routine clinical setting. | Device: CE Marked Sapheon Closure System<br>* CE Marked Sapheon Closure System in closure of incompetent great saphenous veins GSV in a routine clinical setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative Duplex Ultrasound | The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux. | Immediately Post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious). | Immediately post-op through 6 month Follow-up FU |