Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Visible Varicosities; Great Saphenous Vein Incompetence

Treatments: Drug: Endovenous ablation+polidocanol injectable foam 2.0%; Drug: endovenous ablation+polidocanol injectable microfoam 0.125%; Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01197833

VAP.VV017

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 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.

Enrollment: 117 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 3 patient groups

Endovenous ablation+polidocanol injectable microfoam 0.125%

Experimental group

Description:

Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein

Treatment:

Drug: endovenous ablation+polidocanol injectable microfoam 0.125%

Endovenous ablation+polidocanol injectable micrfoam, 1.0%

Experimental group

Description:

Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein

Treatment:

Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%

endovenous ablation+vehicle (placebo)

Active Comparator group

Description:

endovenous ablation followed by injection of vehicle (placebo) to target vein

Treatment:

Drug: Endovenous ablation+polidocanol injectable foam 2.0%