A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"
Overview
- Phase
- Phase 3
- Intervention
- polidocanol injectable foam, 0.125%
- Conditions
- Varicose Veins
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 235
- Primary Endpoint
- Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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 three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.
Investigators
Eligibility Criteria
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 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 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
Arms & Interventions
polidocanol injectable foam, 0.125%
Intervention: polidocanol injectable foam, 0.125%
polidocanol injectable foam, 0.5%
Intervention: polidocanol injectable foam, 0.5%
polidocanol injectable foam, 1.0%
Intervention: polidocanol injectable foam, 1.0%
Vehicle
Intervention: Vehicle
Outcomes
Primary Outcomes
Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)
Time Frame: 8 weeks
The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.
Secondary Outcomes
- Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)(8 weeks)
- Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance(8 weeks)