Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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"
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Age between 18 and 60 years
* Clinical, etiologic, anatomic, pathophysiologic (CEAP): clinical grades 2 to 5 (C2-5), primary (Ep), superficial (As) and reflux only (Pr)
* Duplex scan confirmed primary bilateral GSV insufficiency requiring surgery (insufficiency with reverse venous flow was regarded significant if persisting more than 0.5 seconds in a standing position)
* Duplex scan confirmed suitability for RFA (see exclusion criteria)
* Patients able to give informed consent

Exclusion Criteria:

* Varicose veins without GSV insufficiency on duplex scan
* Previous varicose vein surgery
* Associated small saphenous vein reflux, duplication of the GSV at the SFJ, deep venous insufficiency or previous DVT on duplex scan
* GSV diameter \<3 mm or \>12 mm in the supine position
* Thrombus in the GSV
* Patients with a pacemaker or internal defibrillator
* Concomitant peripheral arterial disease (ankle-brachial pressure index of \<0.9)
* Patients on oral anticoagulants
* Patients with high blood pressure not controlled by medication
* Patients with known thrombophilia, cancer or lupus
* Pregnancy
B: 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.
C: Inclusion Criteria:

* all patients included in previous FOAM study

Exclusion Criteria:

* no received informed consent
D: Inclusion Criteria:

* primary insufficient GSV confirmed by US: reflux\>0.5 sec and diameter\>0.5cm.
* non-treated insufficient GSV
* \>18 years
* informed consent

Exclusion Criteria:

* acute thrombosis or phlebitis
* absence of deep venous system
* vascular syndromes
* use of anticoagulants
* contraindications surgery

Answer: B