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

Primary Purpose

Varicose Veins

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
polidocanol injectable foam, 0.125%
polidocanol injectable foam, 0.5%
polidocanol injectable foam, 1.0%
Vehicle
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring varicose veins

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

polidocanol injectable foam, 0.125%

polidocanol injectable foam, 0.5%

polidocanol injectable foam, 1.0%

Vehicle

Arm Description

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 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)
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
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).

Full Information

First Posted
October 22, 2010
Last Updated
April 19, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01231373
Brief Title
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Acronym
VANISH-2
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 Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
August 2014 (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 Endovenous Microfoam (PEM) 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
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polidocanol injectable foam, 0.125%
Arm Type
Experimental
Arm Title
polidocanol injectable foam, 0.5%
Arm Type
Experimental
Arm Title
polidocanol injectable foam, 1.0%
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
polidocanol injectable foam, 0.125%
Intervention Description
active placebo for blinding
Intervention Type
Drug
Intervention Name(s)
polidocanol injectable foam, 0.5%
Intervention Description
0.5% polidocanol foam injection
Intervention Type
Drug
Intervention Name(s)
polidocanol injectable foam, 1.0%
Intervention Description
1.0% polidocanol foam injection
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
injection of vehicle comparator
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 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.
Time Frame
8 weeks
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 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).
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 (0-4, where 0=none and 4=very severe visible varicose veins).
Time Frame
8 weeks

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 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
Facility Information:
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
City
Los Alamos
State/Province
New Mexico
ZIP/Postal Code
87544
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15143
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26992303
Citation
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.
Results Reference
derived

Learn more about this trial

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

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