Status:
COMPLETED
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Varicose Veins
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ultra...
Eligibility Criteria
Inclusion
- Male or female; age of consent to 75 years
- Baseline VEINES-Sym Questionnaire score less than 75 points
- Superficial venous disease manifested by both symptoms and visible varicosities
- Varicose vein clinical classification CEAP 2 through 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
- Ability to comprehend and sign an informed consent document and complete study questionnaires in English
Exclusion
- Incompetence of the small saphenous vein (SSV)
- Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
- Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
- Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
- Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
- 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.
- History of pulmonary embolism or stroke.
- Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
- Current anticoagulation therapy (within 7 days of enrollment).
- Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening.
- Previous treatment in this study or in a previous Varisolve® study.
- 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.
- Known allergic response to polidocanol, or severe and multiple allergic reactions.
- 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.
- Pregnant or lactating women.
- Current alcohol or drug abuse.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00928421
Start Date
June 1 2009
End Date
January 1 2010
Last Update
May 13 2021
Active Locations (1)
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1
Bellevue, Washington, United States