Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)
Primary Purpose
Varicose Veins
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Polidocanol injectable foam (PEM)
Placebo Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring Varicose Veins
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Polidocanol injectable foam 0.125%
Polidocanol injectable foam 0.5%
Polidocanol injectable foam 1.0%
Polidocanol injectable foam 2.0%
Vehicle
Arm Description
Polidocanol injectable foam 0.125%
Polidocanol injectable foam 0.5%
Polidocanol injectable foam 1.0%
Polidocanol injectable foam 2.0%
Injection of vehicle comparator
Outcomes
Primary Outcome Measures
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 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
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 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).
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 (where 0=none to 4=very severe visible varicose veins).
Full Information
NCT ID
NCT01072877
First Posted
February 19, 2010
Last Updated
April 19, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01072877
Brief Title
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Acronym
VANISH-1
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 Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Varicose Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
279 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polidocanol injectable foam 0.125%
Arm Type
Experimental
Arm Description
Polidocanol injectable foam 0.125%
Arm Title
Polidocanol injectable foam 0.5%
Arm Type
Experimental
Arm Description
Polidocanol injectable foam 0.5%
Arm Title
Polidocanol injectable foam 1.0%
Arm Type
Experimental
Arm Description
Polidocanol injectable foam 1.0%
Arm Title
Polidocanol injectable foam 2.0%
Arm Type
Experimental
Arm Description
Polidocanol injectable foam 2.0%
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Injection of vehicle comparator
Intervention Type
Drug
Intervention Name(s)
Polidocanol injectable foam (PEM)
Intervention Description
Injection of Polidocanol injectable foam
Intervention Type
Drug
Intervention Name(s)
Placebo Vehicle
Intervention Description
Placebo vehicle
Primary Outcome Measure Information:
Title
Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Description
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
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Description
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).
Time Frame
8 weeks
Title
Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Description
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).
Time Frame
8 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
North Tonawanda
State/Province
New York
ZIP/Postal Code
14120
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
10530
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26384639
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
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