Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities

NCT ID: NCT01197833

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-12-31

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 two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.

Conditions

Great Saphenous Vein Incompetence; Visible Varicosities

Study Design

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

Study Groups

Endovenous ablation+polidocanol injectable microfoam 0.125%

Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein

Group Type: EXPERIMENTAL

endovenous ablation+polidocanol injectable microfoam 0.125%

Intervention Type: DRUG

All components except API

Endovenous ablation+polidocanol injectable micrfoam, 1.0%

Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein

Group Type: EXPERIMENTAL

Endovenous ablation+polidocanol injectable microfoam 1.0%

Intervention Type: DRUG

endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%

endovenous ablation+vehicle (placebo)

endovenous ablation followed by injection of vehicle (placebo) to target vein

Group Type: ACTIVE_COMPARATOR

Endovenous ablation+polidocanol injectable foam 2.0%

Intervention Type: DRUG

Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

Interventions

endovenous ablation+polidocanol injectable microfoam 0.125%

All components except API

Intervention Type: DRUG

Endovenous ablation+polidocanol injectable microfoam 1.0%

endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%

Intervention Type: DRUG

Endovenous ablation+polidocanol injectable foam 2.0%

Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

Intervention Type: DRUG

Other Intervention Names

endovenous ablation followed by polidocanol endovenous microfoam 0.125% injection to target vein; Endovenous ablation followed by injection of polidocanol injectable foam 1.0% to target vein; Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

Eligibility Criteria

Inclusion Criteria

• Incompetence of SFJ
• Patients who are candidates for ETA [laser or radiofrequency ablation (RFA)]
• Symptomatic varicose veins
• Visible varicose veins
• Ability to comprehend and sign an informed consent and complete study questionnaires in English

Exclusion Criteria

• Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)
• Patients who have active ulceration on the leg to be treated (Clinical Finding C6, as assessed by CEAP Classification of Venous Disorders)
• Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings
• Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
• Deep venous reflux unless clinically insignificant in comparison to superficial reflux
• Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
• Reduced mobility
• History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound
• 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

• 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

Scottsdale, Arizona, United States

Bradenton, Florida, United States

Oak Brook, Illinois, United States

North Tonawanda, New York, United States

Stony Brook, New York, United States

Charlotte, North Carolina, United States

Kirkland, Washington, United States

Countries

United States

References

Vasquez M, Gasparis AP; Varithena(R) 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017 May;32(4):272-281. doi: 10.1177/0268355516637300. Epub 2016 Mar 7.

Reference Type: DERIVED

PMID: 26957489 (View on PubMed)

Other Identifiers

VAP.VV017

Identifier Type: -

Identifier Source: org_study_id