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

• ClinicalTrials.gov Identifier: NCT01231373
• Recruitment Status: Completed
• First Posted: November 1, 2010
• Results First Posted: April 2, 2014
• Last Update Posted: April 21, 2021
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

Brief Summary:

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 or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 235 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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"
• Study Start Date: November 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) [ Time Frame: 8 weeks ]
   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 :

1. Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) [ Time Frame: 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 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).
2. Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance [ Time Frame: 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 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Locations

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

Boston Scientific Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01231373
• Other Study ID Numbers: VAP.VV016
• First Posted: November 1, 2010
• Results First Posted: April 2, 2014
• Last Update Posted: April 21, 2021
• Last Verified: April 2021

Keywords provided by Boston Scientific Corporation:

varicose veins

Additional relevant MeSH terms:

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Polidocanol; Sclerosing Solutions; Pharmaceutical Solutions