Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency
Brief Summary: A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.


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 (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
* Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure 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:

* 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
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: D