Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Condition: Great Saphenous Vein Incompetence; Visible Varicosities
MeSH terms: Varicose Veins
Intervention: endovenous ablation+polidocanol injectable microfoam 0.125%; Endovenous ablation+polidocanol injectable microfoam 1.0%; Endovenous ablation+polidocanol injectable foam 2.0%
Intervention description: All components except API; endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%; Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Intervention MeSH terms: Polidocanol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: varicose veins; Great saphenous vein; varicosities

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 two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM)
      compared to vehicle (inactive solution) when used following an approved heat treatment in
      subjects with varicose veins.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Incompetence of SFJ

          -  Patients who are candidates for ETA [laser or radiofrequency ablation (RFA)]

          -  Symptomatic varicose veins

          -  Visible varicose veins

          -  Ability to comprehend and sign an informed consent and complete study questionnaires
             in English

        Exclusion Criteria:

          -  Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as
             assessed by CEAP Classification of Venous Disorders)

          -  Patients who have active ulceration on the leg to be treated (Clinical Finding C6, 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 venous reflux unless clinically insignificant in comparison to superficial reflux

          -  Peripheral arterial disease precluding the wearing of post-procedure compression
             bandaging and stockings

          -  Reduced mobility

          -  History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of
             prior DVT on duplex ultrasound

          -  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