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

Last updated: April 19, 2021
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

3

Condition

Varicose Veins

Vascular Diseases

Occlusions

Treatment

N/A

Clinical Study ID

NCT01197833
VAP.VV017
  • Ages 18-75
  • All Genders

Study 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

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 questionnairesin English

Exclusion

Exclusion Criteria:

  • Patients who only have telangiectatic or reticular veins (Clinical Finding C1, asassessed by CEAP Classification of Venous Disorders)
  • Patients who have active ulceration on the leg to be treated (Clinical Finding C6, asassessed by CEAP Classification of Venous Disorders)
  • Leg obesity impairing the ability to access the vein to be treated and/or to applypost-procedure compression bandaging and stockings
  • Ultrasonographic or other evidence of current or previous deep vein thrombosis orocclusion
  • Deep venous reflux unless clinically insignificant in comparison to superficial reflux
  • Peripheral arterial disease precluding the wearing of post-procedure compressionbandaging and stockings
  • Reduced mobility
  • History of deep vein thrombosis, pulmonary embolism or stroke, including evidence ofprior 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 hepaticinsufficiency; serious skin disease/condition that may compromise the ability of thepatient to comply with the compression protocol, etc.)
  • Known allergic response to polidocanol or heparin, including history ofheparin-induced thrombocytopenia, and/or multiple allergic reactions
  • Current alcohol or drug abuse
  • Pregnant or lactating women
  • Women of childbearing potential not using effective contraception

Study Design

Total Participants: 117
Study Start date:
September 01, 2010
Estimated Completion Date:
December 31, 2012

Connect with a study center

  • Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Bradenton, Florida 34209
    United States

    Site Not Available

  • Oak Brook, Illinois 60523
    United States

    Site Not Available

  • North Tonawanda, New York 14120
    United States

    Site Not Available

  • Stony Brook, New York 11974
    United States

    Site Not Available

  • Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Kirkland, Washington 98034
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.