Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-2)

This study has been completed.
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
First received: October 22, 2010
Last updated: February 19, 2015
Last verified: February 2015
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 concentrations 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 injectable foam, 0.125%
Drug: polidocanol injectable foam, 0.5%
Drug: polidocanol injectable foam, 1.0%
Drug: 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% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"

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 (VVSymQ Score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.

Secondary Outcome Measures:
  • Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) [ Time Frame: 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 single-item paper questionnaire, the instructions included a diagram fo 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).

  • Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance [ Time Frame: 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 baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians, evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (0-4, where 0=none and 4=very severe visible varicose veins).

Enrollment: 235
Study Start Date: November 2010
Study Completion Date: August 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polidocanol injectable foam, 0.125% Drug: polidocanol injectable foam, 0.125%
active placebo for blinding
Experimental: polidocanol injectable foam, 0.5% Drug: polidocanol injectable foam, 0.5%
0.5% polidocanol foam injection
Experimental: polidocanol injectable foam, 1.0% Drug: polidocanol injectable foam, 1.0%
1.0% polidocanol foam injection
Placebo Comparator: Vehicle Drug: Vehicle
injection of vehicle comparator


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
  • 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 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 vein reflux unless clinically insignificant in comparison to superficial reflux
  • 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
  • History of DVT, pulmonary embolism, or stroke
  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: NCT01231373

United States, Alabama
Dothan, Alabama, United States, 36303
United States, California
San Diego, California, United States, 92120
San Diego, California, United States, 92121
United States, Indiana
Lafayette, Indiana, United States, 47905
United States, Maryland
Frederick, Maryland, United States, 21701
Hunt Valley, Maryland, United States, 21030
United States, New Mexico
Los Alamos, New Mexico, United States, 87544
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Monroeville, Pennsylvania, United States, 15143
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Washington
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
BTG International Inc.
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01231373     History of Changes
Other Study ID Numbers: VAP.VV016
Study First Received: October 22, 2010
Results First Received: December 20, 2013
Last Updated: February 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
varicose veins

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

ClinicalTrials.gov processed this record on November 30, 2015