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

• ClinicalTrials.gov Identifier: NCT00928421
• Recruitment Status: Completed
• First Posted: June 26, 2009
• Results First Posted: April 2, 2014
• Last Update Posted: May 13, 2021
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

Brief Summary:

To determine the effect and safety of Varisolve® 0.125% [0.2%]

Condition or disease	Intervention/treatment	Phase
Varicose Veins	Drug: Polidocanol Endovenous Microfoam 0.125%	Phase 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: January 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Varisolve 0.125%	Drug: Polidocanol Endovenous Microfoam 0.125%; Polidocanol Endovenous Microfoam 0.125%, single dose; Other Name: Varisolve 0.125%

Outcome Measures

Primary Outcome Measures :

1. Responders to Treatment, Assessed by Duplex Ultrasound [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Washington

Bellevue, Washington, United States

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Study Chair: Ellen Evans; BTG International Inc.

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00928421
• Other Study ID Numbers: VAP.VV014
• First Posted: June 26, 2009
• Results First Posted: April 2, 2014
• Last Update Posted: May 13, 2021
• Last Verified: April 2021

Keywords provided by Boston Scientific Corporation:

Varicose Veins

Additional relevant MeSH terms:

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Polidocanol; Sclerosing Solutions; Pharmaceutical Solutions