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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01197833
First received: September 8, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Great Saphenous Vein Incompetence
Visible Varicosities
Drug: endovenous ablation+polidocanol injectable microfoam 0.125%
Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%
Drug: Endovenous ablation+polidocanol injectable foam 2.0%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) [ Time Frame: IPR-V3 measured at baseline and then at 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Absolute Change From Baseline in PA-V3 Score [ Time Frame: PA-V3 measured at baseline and then at 8 weeks ] [ Designated as safety issue: No ]
    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)


Enrollment: 117
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197833

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85255
United States, Florida
Bradenton, Florida, United States, 34209
United States, Illinois
Oak Brook, Illinois, United States, 60523
United States, New York
North Tonawanda, New York, United States, 14120
Stony Brook, New York, United States, 11974
United States, North Carolina
Charlotte, North Carolina, United States, 28207
United States, Washington
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
BTG International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01197833     History of Changes
Other Study ID Numbers: VAP.VV017
Study First Received: September 8, 2010
Results First Received: February 7, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
varicose veins
Great saphenous vein
varicosities

Additional relevant MeSH terms:
Varicose Veins
Cardiovascular Diseases
Vascular Diseases
Polidocanol
Cardiovascular Agents
Pharmaceutical Solutions
Pharmacologic Actions
Sclerosing Solutions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014