Varicose Veins
Conditions
Keywords
Varicose Veins
Brief summary
To determine the effect and safety of Varisolve® 0.125% \[0.2%\]
Detailed description
In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% \[0.2%\] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein
Interventions
DRUGPolidocanol Endovenous Microfoam 0.125%
Polidocanol Endovenous Microfoam 0.125%, single dose
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female; age of consent to 75 years 2. Baseline VEINES-Sym Questionnaire score less than 75 points 3. Superficial venous disease manifested by both symptoms and visible varicosities 4. Varicose vein clinical classification CEAP 2 through 5 5. Incompetence of SFJ (reflux \> 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein 6. Ability to comprehend and sign an informed consent document and complete study questionnaires in English
Exclusion criteria
1. Incompetence of the small saphenous vein (SSV) 2. Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence 3. Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations. 4. Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression. 5. Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day). 6. Planned prolonged automobile, bus, or air travel within 4 weeks following treatment, unless the patient can walk for at least 5 consecutive minutes every hour during travel. 7. History of pulmonary embolism or stroke. 8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening. 9. Current anticoagulation therapy (within 7 days of enrollment). 10. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening. 11. Previous treatment in this study or in a previous Varisolve® study. 12. 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.) or clinically significant laboratory abnormalities. 13. Known allergic response to polidocanol, or severe and multiple allergic reactions. 14. Women of childbearing potential not using effective contraception for at least one month prior to study enrollment and/or unwilling to continue birth control until their last study visit. 15. Pregnant or lactating women. 16. Current alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responders to Treatment, Assessed by Duplex Ultrasound | 8 weeks | Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polidocanol Injectable Foam 0.125% polidocanol injectable foam 0.125%, single dose | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Polidocanol Injectable Foam 0.125% |
|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 10.44 |
| Body Mass Index | 29.0 kg/m^2 STANDARD_DEVIATION 6.73 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Responders to Treatment, Assessed by Duplex Ultrasound
Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Polidocanol Injectable Foam 0.125% | Responders to Treatment, Assessed by Duplex Ultrasound | 9 participants |