An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins

Phase 2

Completed

• Conditions: Varicose Veins
• Interventions: Drug: Polidocanol Endovenous Microfoam 0.125%

• Registration Number: NCT00928421
• Lead Sponsor: Boston Scientific Corporation

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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Disposition First Submitted: 2011-09-14
• Disposition First Submitted QC: 2011-09-14
• Disposition First Posted: 2011-09-21
• Results First Submitted: 2014-02-19
• Results First Submitted QC: 2014-02-19
• Results First Posted: 2014-04-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Varisolve 0.125%	Polidocanol Endovenous Microfoam 0.125%	-

Primary Outcome Measures

Name	Time	Method
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.