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

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"

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Drug: polidocanol injectable foam, 0.125%; Drug: polidocanol injectable foam, 0.5%; Drug: polidocanol injectable foam, 1.0%; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle; injection of vehicle comparator
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)	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).	8 weeks
Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance	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).	8 weeks

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Publications and helpful links

General Publications

• Todd KL 3rd, Wright DI; VANISH-2 Investigator Group. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):258-264.e1. doi: 10.1016/j.jvsv.2015.03.003. Epub 2015 May 6.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (ESTIMATE): November 1, 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: varicose veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: VAP.VV016