Efficacy and Safety Study of Varisolve™ Polidocanol Endovenous Microfoam (PEM)for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc. ( BTG Ltd. )
ClinicalTrials.gov Identifier:
NCT01072877
First received: February 19, 2010
Last updated: December 9, 2013
Last verified: December 2013
  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 three different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Condition Intervention Phase
Varicose Veins
Drug: Polidocanol Endovenous Microfoam (PEM)
Drug: Placebo Vehicle
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 Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve™ Polidocanol Endovenous Microfoam (PEM) 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Change in patient-reported symptoms of varicose veins [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The absolute change from Baseline in symptom score.


Secondary Outcome Measures:
  • Change in appearance as rated by patient and central independent photography review [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The abolsute change form Baseline in appearance score.


Enrollment: 250
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polidocanol endovenous microfoam 0.125%
Polidocanol endovenous microfoam 0.125%
Drug: Polidocanol Endovenous Microfoam (PEM)
Injection of Polidocanol Endovenous Microfoam
Other Name: PEM
Experimental: Polidocanol endovenous microfoam 0.5%
Polidocanol endovenous microfoam 0.5%
Drug: Polidocanol Endovenous Microfoam (PEM)
Injection of Polidocanol Endovenous Microfoam
Other Name: PEM
Experimental: Polidocanol endovenous microfoam 1.0%
Polidocanol endovenous microfoam 1.0%
Drug: Polidocanol Endovenous Microfoam (PEM)
Injection of Polidocanol Endovenous Microfoam
Other Name: PEM
Experimental: Polidocanol endovenous microfoam 2.0%
Polidocanol endovenous microfoam 2.0%
Drug: Polidocanol Endovenous Microfoam (PEM)
Injection of Polidocanol Endovenous Microfoam
Other Name: PEM
Placebo Comparator: Vehicle
Injection of vehicle comparator
Drug: Placebo Vehicle
Placebo vehicle
Other Name: Placebo vehicle

  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
  • Ability to comprehend and sign an informed consent document and complete study questionnaires in English
  • Ability to record symptoms in accordance with the protocol
  • Symptomatic varicose veins
  • Visible varicose veins

Exclusion Criteria:

  • Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
  • Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings
  • Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
  • Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
  • Reduced mobility
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072877

Locations
United States, California
Laguna Hills, California, United States, 92653
San Diego, California, United States
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Aventura, Florida, United States, 33180
Bradenton, Florida, United States, 34209
United States, Illinois
Oakbrook Terrace, Illinois, United States, 60181
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Kalamazoo, Michigan, United States, 49009
United States, New York
Hartsdale, New York, United States, 10530
New York, New York, United States, 10016
North Towanda, New York, United States, 14120
Stony Brook, New York, United States, 10530
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Durham, North Carolina, United States, 27705
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Toledo, Ohio, United States, 43606
United States, Oregon
Bend, Oregon, United States, 97701
United States, Tennessee
Clarksville, Tennessee, United States, 37040
United States, Washington
Kirkland, Washington, United States, 98034
Spokane, Washington, United States, 99204
Sponsors and Collaborators
BTG Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: BTG International Inc. ( BTG Ltd. )
ClinicalTrials.gov Identifier: NCT01072877     History of Changes
Other Study ID Numbers: VAP.VV015
Study First Received: February 19, 2010
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
Varicose Veins

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

ClinicalTrials.gov processed this record on April 22, 2014