Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Varicose Veins

Treatments: Drug: Placebo Vehicle; Drug: Polidocanol injectable foam (PEM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01072877

VAP.VV015

Details and patient eligibility

About

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 injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Enrollment: 279 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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279 participants in 5 patient groups, including a placebo group

Polidocanol injectable foam 0.125%

Experimental group

Description:

Polidocanol injectable foam 0.125%

Treatment:

Drug: Polidocanol injectable foam (PEM)

Polidocanol injectable foam 0.5%

Experimental group

Description:

Polidocanol injectable foam 0.5%

Treatment:

Drug: Polidocanol injectable foam (PEM)

Polidocanol injectable foam 1.0%

Experimental group

Description:

Polidocanol injectable foam 1.0%

Treatment:

Drug: Polidocanol injectable foam (PEM)

Polidocanol injectable foam 2.0%

Experimental group

Description:

Polidocanol injectable foam 2.0%

Treatment:

Drug: Polidocanol injectable foam (PEM)

Vehicle

Placebo Comparator group

Description:

Injection of vehicle comparator

Treatment:

Drug: Placebo Vehicle