Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

NCT ID: NCT01072877

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-11-30

Brief Summary

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Polidocanol injectable foam 0.125%

Polidocanol injectable foam 0.125%

Group Type: EXPERIMENTAL

Polidocanol injectable foam (PEM)

Intervention Type: DRUG

Injection of Polidocanol injectable foam

Polidocanol injectable foam 0.5%

Polidocanol injectable foam 0.5%

Group Type: EXPERIMENTAL

Polidocanol injectable foam (PEM)

Intervention Type: DRUG

Injection of Polidocanol injectable foam

Polidocanol injectable foam 1.0%

Polidocanol injectable foam 1.0%

Group Type: EXPERIMENTAL

Polidocanol injectable foam (PEM)

Intervention Type: DRUG

Injection of Polidocanol injectable foam

Polidocanol injectable foam 2.0%

Polidocanol injectable foam 2.0%

Group Type: EXPERIMENTAL

Polidocanol injectable foam (PEM)

Intervention Type: DRUG

Injection of Polidocanol injectable foam

Vehicle

Injection of vehicle comparator

Group Type: PLACEBO_COMPARATOR

Placebo Vehicle

Intervention Type: DRUG

Placebo vehicle

Interventions

Polidocanol injectable foam (PEM)

Injection of Polidocanol injectable foam

Intervention Type: DRUG

Placebo Vehicle

Placebo vehicle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
• Ability to comprehend and sign an informed consent document and complete study questionnaires in English
• Ability to record symptoms in accordance with the protocol
• Symptomatic varicose veins
• Visible varicose veins

Exclusion Criteria

• Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
• Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings
• Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
• Deep vein reflux unless clinically insignificant in comparison to superficial reflux
• Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
• Reduced mobility
• Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
• 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.)
• Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
• Current alcohol or drug abuse
• Pregnant or lactating women
• Women of childbearing potential not using effective contraception
• History of DVT, pulmonary embolism or stroke

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hartsdale, New York, United States

New York, New York, United States

North Tonawanda, New York, United States

Stony Brook, New York, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Winston-Salem, North Carolina, United States

Toledo, Ohio, United States

Bend, Oregon, United States

Clarksville, Tennessee, United States

Kirkland, Washington, United States

Spokane, Washington, United States

Laguna Hills, California, United States

San Diego, California, United States

Washington D.C., District of Columbia, United States

Aventura, Florida, United States

Bradenton, Florida, United States

Oakbrook Terrace, Illinois, United States

Ann Arbor, Michigan, United States

Kalamazoo, Michigan, United States

Countries

United States

References

King JT, O'Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16.

Reference Type: DERIVED

PMID: 26384639 (View on PubMed)

Other Identifiers

VAP.VV015

Identifier Type: -

Identifier Source: org_study_id