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Also known as Varisolve (Polidocanol Endovenous Microfoam)
Varisolve · 1 trial · 1 indication
The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Varisolve (polidocanol endovenous mircofoam) |
| 2 | PLACEBO_COMPARATOR | Agitated saline |
| Name | Type | Description |
|---|---|---|
| Varisolve (Polidocanol Endovenous Microfoam) | DRUG | 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2) |
| Agitated Saline | DRUG | 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session |
Inclusion Criteria: * Males and Females 18-65 years old * VEINES Sym Score less than 75 points * Varicose Vein clinical classification CEAP 2, 3, 4, or 5 * Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein * Superficial venous disease manifested by both sympt...
Varisolve is being developed for the treatment of symptomatic, visible varicose veins with saphenofemoral junction incompetence. It is an injectable foam treatment studied in adults 18 years and older. The program is in Phase 2 clinical development, so Varisolve is investigational and is not an approved therapy.
Varisolve is developed by Boston Scientific Corporation, which trades on the New York Stock Exchange under the ticker BSX. Boston Scientific is the sponsor of the clinical program evaluating the agent in varicose veins.
Varisolve is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. Because it remains investigational, Varisolve has not been established as an approved treatment for varicose veins.
Varisolve has been studied in one completed Phase 2 trial, NCT00758420, titled a randomized, single blind, placebo controlled study to evaluate efficacy and safety of polidocanol injectable foam for treatment of symptomatic, visible varicose veins with SFJ incompetence. The trial enrolled 77 participants in the United States and was placebo controlled and randomized.
Yes. Varisolve is also known as Varisolve (Polidocanol Endovenous Microfoam). The two names refer to the same investigational product, an injectable polidocanol foam formulation being studied for symptomatic, visible varicose veins with saphenofemoral junction incompetence.
The completed Phase 2 trial of Varisolve, NCT00758420, enrolled 77 participants. It was a randomized, single blind, placebo controlled study conducted in the United States in adults aged 18 years and older with symptomatic, visible varicose veins with SFJ incompetence.