Clinical trial NCT00928421: An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
Official title: An Open-label, Single-dose Pilot Study to Evaluate the Efficacy and Safety of Varisolve® (Polidocanol Endovenous Microfoam) 0.125% [0.2%] for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Varicose Veins
Keywords: Varicose Veins
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Responders to Treatment, Assessed by Duplex Ultrasound
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bellevue
country: United States
state: Washington
Study officials:
affiliation: BTG International Inc.
name: Ellen Evans
role: STUDY_CHAIR
References: