Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

• ClinicalTrials.gov Identifier: NCT01072877
• Recruitment Status: Completed
• First Posted: February 22, 2010
• Results First Posted: May 16, 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 injectable foam 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 (PEM); Drug: Placebo Vehicle	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 279 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 Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
• Study Start Date: December 2010
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: November 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Polidocanol injectable foam 0.125%; Polidocanol injectable foam 0.125%	Drug: Polidocanol injectable foam (PEM); Injection of Polidocanol injectable foam
Experimental: Polidocanol injectable foam 0.5%; Polidocanol injectable foam 0.5%	Drug: Polidocanol injectable foam (PEM); Injection of Polidocanol injectable foam
Experimental: Polidocanol injectable foam 1.0%; Polidocanol injectable foam 1.0%	Drug: Polidocanol injectable foam (PEM); Injection of Polidocanol injectable foam
Experimental: Polidocanol injectable foam 2.0%; Polidocanol injectable foam 2.0%	Drug: Polidocanol injectable foam (PEM); Injection of Polidocanol injectable foam
Placebo Comparator: Vehicle; Injection of vehicle comparator	Drug: Placebo Vehicle; Placebo vehicle

Outcome Measures

Primary Outcome Measures :

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

   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 of 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 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching).

   The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity).

   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 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).
2. Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance [ Time Frame: 8 weeks post treatment ]
   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 (where 0=none to 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 (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
• 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, 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 Tonawanda, 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

Boston Scientific Corporation

More Information

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

King JT, O'Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01072877
• Other Study ID Numbers: VAP.VV015
• First Posted: February 22, 2010
• Results First Posted: May 16, 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