European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study (eSCOPE)

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.