Clinical trial NCT01197833: Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Official title: A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Great Saphenous Vein Incompetence
Visible Varicosities
Keywords: varicose veins
Great saphenous vein
varicosities
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
timeFrame: IPR-V3 measured at baseline and then at 8 weeks
measure: Absolute Change From Baseline in PA-V3 Score
timeFrame: PA-V3 measured at baseline and then at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Bradenton
country: United States
state: Florida
city: Oak Brook
country: United States
state: Illinois
city: North Tonawanda
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Kirkland
country: United States
state: Washington
Study officials:
References:
citation: 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.