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Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

Primary Purpose

Great Saphenous Vein Incompetence, Visible Varicosities

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
endovenous ablation+polidocanol injectable microfoam 0.125%
Endovenous ablation+polidocanol injectable microfoam 1.0%
Endovenous ablation+polidocanol injectable foam 2.0%
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Great Saphenous Vein Incompetence focused on measuring varicose veins, Great saphenous vein, varicosities

Eligibility Criteria

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

Inclusion Criteria:

  • Incompetence of SFJ
  • Patients who are candidates for ETA [laser or radiofrequency ablation (RFA)]
  • Symptomatic varicose veins
  • Visible varicose veins
  • Ability to comprehend and sign an informed consent and complete study questionnaires in English

Exclusion Criteria:

  • Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)
  • Patients who have active ulceration on the leg to be treated (Clinical Finding C6, 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 venous reflux unless clinically insignificant in comparison to superficial reflux
  • Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
  • Reduced mobility
  • History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound
  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Endovenous ablation+polidocanol injectable microfoam 0.125%

Endovenous ablation+polidocanol injectable micrfoam, 1.0%

endovenous ablation+vehicle (placebo)

Arm Description

Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein

Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein

endovenous ablation followed by injection of vehicle (placebo) to target vein

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
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 screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
Absolute Change From Baseline in PA-V3 Score
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 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)

Secondary Outcome Measures

Full Information

First Posted
September 8, 2010
Last Updated
April 19, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01197833
Brief Title
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Acronym
017
Official Title
A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 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 two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Great Saphenous Vein Incompetence, Visible Varicosities
Keywords
varicose veins, Great saphenous vein, varicosities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovenous ablation+polidocanol injectable microfoam 0.125%
Arm Type
Experimental
Arm Description
Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein
Arm Title
Endovenous ablation+polidocanol injectable micrfoam, 1.0%
Arm Type
Experimental
Arm Description
Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein
Arm Title
endovenous ablation+vehicle (placebo)
Arm Type
Active Comparator
Arm Description
endovenous ablation followed by injection of vehicle (placebo) to target vein
Intervention Type
Drug
Intervention Name(s)
endovenous ablation+polidocanol injectable microfoam 0.125%
Other Intervention Name(s)
endovenous ablation followed by polidocanol endovenous microfoam 0.125% injection to target vein
Intervention Description
All components except API
Intervention Type
Drug
Intervention Name(s)
Endovenous ablation+polidocanol injectable microfoam 1.0%
Other Intervention Name(s)
Endovenous ablation followed by injection of polidocanol injectable foam 1.0% to target vein
Intervention Description
endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%
Intervention Type
Drug
Intervention Name(s)
Endovenous ablation+polidocanol injectable foam 2.0%
Other Intervention Name(s)
Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Intervention Description
Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
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 screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
Time Frame
IPR-V3 measured at baseline and then at 8 weeks
Title
Absolute Change From Baseline in PA-V3 Score
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 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
PA-V3 measured at baseline and then at 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 Patients who are candidates for ETA [laser or radiofrequency ablation (RFA)] Symptomatic varicose veins Visible varicose veins Ability to comprehend and sign an informed consent and complete study questionnaires in English Exclusion Criteria: Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders) Patients who have active ulceration on the leg to be treated (Clinical Finding C6, 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 venous reflux unless clinically insignificant in comparison to superficial reflux Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings Reduced mobility History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound 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
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
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
11974
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26957489
Citation
Vasquez M, Gasparis AP; Varithena(R) 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017 May;32(4):272-281. doi: 10.1177/0268355516637300. Epub 2016 Mar 7.
Results Reference
derived

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Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities

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