Great Saphenous Vein Incompetence, Visible Varicosities
Conditions
Keywords
varicose veins, Great saphenous vein, varicosities
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 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.
Interventions
DRUGendovenous ablation+polidocanol injectable microfoam 0.125%
All components except API
DRUGEndovenous ablation+polidocanol injectable microfoam 1.0%
endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%
DRUGEndovenous ablation+polidocanol injectable foam 2.0%
Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovenous Ablation, Vehicle Placebo Endovenous ablation followed by vehicle placebo | 38 |
| Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous ablation followed by polidocanol injectable foam, 0.5% | 39 |
| Endovenous Ablation, Polidocanol Injectable Foam 1.0% endovenous ablation followed by polidocanol injectable foam 1.0% | 40 |
| Total | 117 |
Baseline characteristics
| Characteristic | Endovenous Ablation, Vehicle Placebo | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | Total |
|---|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 12.05 | 50.1 years STANDARD_DEVIATION 11.6 | 51.8 years STANDARD_DEVIATION 9.75 | 52.0 years STANDARD_DEVIATION 11.18 |
| BMI | 29.3 kg^m2 STANDARD_DEVIATION 6.04 | 27.7 kg^m2 STANDARD_DEVIATION 4.58 | 28.1 kg^m2 STANDARD_DEVIATION 5.25 | 28.3 kg^m2 STANDARD_DEVIATION 5.32 |
| Sex: Female, Male Female | 26 Participants | 29 Participants | 26 Participants | 81 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 14 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 38 | 29 / 39 | 35 / 40 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 | 0 / 40 |
Outcome results
Primary
Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
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.
Time frame: IPR-V3 measured at baseline and then at 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Endovenous Ablation, Vehicle Placebo | Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | -0.80 score | Standard Error 0.102 |
| Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | -1.30 score | Standard Error 0.1 |
| Endovenous Ablation, Polidocanol Injectable Foam 1.0% | Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | -1.11 score | Standard Error 0.097 |
Primary
Absolute Change From Baseline in PA-V3 Score
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)
Time frame: PA-V3 measured at baseline and then at 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Endovenous Ablation, Vehicle Placebo | Absolute Change From Baseline in PA-V3 Score | -1.59 score | Standard Error 0.142 |
| Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | Absolute Change From Baseline in PA-V3 Score | -1.81 score | Standard Error 0.14 |
| Endovenous Ablation, Polidocanol Injectable Foam 1.0% | Absolute Change From Baseline in PA-V3 Score | -1.85 score | Standard Error 0.136 |