Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"
Brief Summary: Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Options:
A: Inclusion Criteria:

* Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
* Ability to comprehend and sign an informed consent document and complete study questionnaires in English
* Ability to record symptoms in accordance with the protocol
* Symptomatic varicose veins
* Visible varicose veins

Exclusion Criteria:

* Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders).
* Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings
* Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
* Deep vein reflux unless clinically insignificant in comparison to superficial reflux
* Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
* Reduced mobility
* Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
* Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
* Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
* Current alcohol or drug abuse
* Pregnant or lactating women
* Women of childbearing potential not using effective contraception
* History of DVT, pulmonary embolism, or stroke
B: 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
C: Inclusion Criteria:

* Males and Females 18-65 years old
* VEINES Sym Score less than 75 points
* Varicose Vein clinical classification CEAP 2, 3, 4, or 5
* Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
* Superficial venous disease manifested by both symptoms and visible varicosities
* Ability to comprehend and sign an informed consent document and completed study questionnaires in English

Exclusion Criteria:

* Incompetence of the SSV which substantially contributes to the filling of visible varicose veins
* Current or previous Deep Vein Thrombosis
* Leg obesity
* Peripheral arterial disease in the leg to be treated
* Reduced mobility
* Planned prolonged travel with limited mobility with in 4 weeks of treatment
* History of pulmonary embolism or stroke
* Major surgery, prolonged hospitalization or pregnancy within 3 months
* Current anticoagulation therapy (within 7 days of enrollment)
* Participation in a clinical study involving a investigational product within 3 months
* Major co-existing disease or clinically significant laboratory abnormalities
* Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions
* Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
* Pregnant or lactating women
* Current alcohol or drug abuse
D: Inclusion Criteria:

* Aged 18 or over
* Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
* Clinical grades C2-C6 on the CEAP system
* Superficial axial incompetence with proposed treatment lengths of at least 10cm
* Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
* Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language

Exclusion Criteria:

* One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
* Unwilling or inability to comply with the requirements for follow-up visits
* Known allergy to medications or dressings used in the treatment
* Known right to left circulatory shunt
* Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
* Pelvic vein insufficiency
* Active or recent thrombophlebitis (within 6 weeks)
* Impalpable foot pulses with an Ankle-Brachial Pressure Index of less than 0.8
* Pregnancy or breast feeding
* Active malignancy
* Immobility
* Involvement in other CTIMP trials within the last 6 months

Answer: A