Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
endovenous ablation+polidocanol injectable microfoam 0.125% · 1 trial · 2 indications
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.
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)
| Arm | Type | Description |
|---|---|---|
| Endovenous ablation+polidocanol injectable microfoam 0.125% | EXPERIMENTAL | Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein |
| Endovenous ablation+polidocanol injectable micrfoam, 1.0% | EXPERIMENTAL | Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein |
| endovenous ablation+vehicle (placebo) | ACTIVE_COMPARATOR | endovenous ablation followed by injection of vehicle (placebo) to target vein |
| Name | Type | Description |
|---|---|---|
| endovenous ablation+polidocanol injectable microfoam 0.125% | DRUG | All components except API |
| Endovenous ablation+polidocanol injectable microfoam 1.0% | DRUG | endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0% |
| Endovenous ablation+polidocanol injectable foam 2.0% | DRUG | Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0% |
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: * ...