Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

April 19, 2021 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
    • Florida
      • Bradenton, Florida, United States, 34209
    • Illinois
      • Oak Brook, Illinois, United States, 60523
    • New York
      • North Tonawanda, New York, United States, 14120
      • Stony Brook, New York, United States, 11974
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
    • Washington
      • Kirkland, Washington, United States, 98034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovenous ablation+polidocanol injectable microfoam 0.125%
Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein
Drug: endovenous ablation+polidocanol injectable microfoam 0.125%
All components except API
Other Names:
  • endovenous ablation followed by polidocanol endovenous microfoam 0.125% injection to target vein
Experimental: Endovenous ablation+polidocanol injectable micrfoam, 1.0%
Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein
Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%
endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%
Other Names:
  • Endovenous ablation followed by injection of polidocanol injectable foam 1.0% to target vein
Active Comparator: endovenous ablation+vehicle (placebo)
endovenous ablation followed by injection of vehicle (placebo) to target vein
Drug: Endovenous ablation+polidocanol injectable foam 2.0%
Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Other Names:
  • Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
Time Frame: IPR-V3 measured at baseline and then at 8 weeks
The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
IPR-V3 measured at baseline and then at 8 weeks
Absolute Change From Baseline in PA-V3 Score
Time Frame: PA-V3 measured at baseline and then at 8 weeks
The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4)
PA-V3 measured at baseline and then at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAP.VV017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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