A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

NCT01197833 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Boston Scientific Corporation
Phase	Phase 3
Status	COMPLETED
Enrolment	117
Start date	2010-09
Completion	2012-12

Conditions

• Great Saphenous Vein Incompetence
• Visible Varicosities

Interventions

• endovenous ablation+polidocanol injectable microfoam 0.125%
• Endovenous ablation+polidocanol injectable microfoam 1.0%
• Endovenous ablation+polidocanol injectable foam 2.0%

Primary outcomes

• Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) — IPR-V3 measured at baseline and then at 8 weeks
  The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
• Absolute Change From Baseline in PA-V3 Score — PA-V3 measured at baseline and then at 8 weeks
  The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4)

Countries

United States