Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

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