Last updated: April 19, 2021
Sponsor: Boston Scientific Corporation
Overall Status: Completed
Phase
2/3
Condition
Occlusions
Varicose Veins
Vascular Diseases
Treatment
N/AClinical Study ID
NCT00758420
VAP.VV013
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and Females 18-65 years old
- VEINES Sym Score less than 75 points
- Varicose Vein clinical classification CEAP 2, 3, 4, or 5
- Incompetence of SFJ associated with incompetence of the GSV or other major accessoryvein
- Superficial venous disease manifested by both symptoms and visible varicosities
- Ability to comprehend and sign an informed consent document and completed studyquestionnaires in English
Exclusion
Exclusion Criteria:
- Incompetence of the SSV which substantially contributes to the filling of visiblevaricose veins
- Current or previous Deep Vein Thrombosis
- Leg obesity
- Peripheral arterial disease in the leg to be treated
- Reduced mobility
- Planned prolonged travel with limited mobility with in 4 weeks of treatment
- History of pulmonary embolism or stroke
- Major surgery, prolonged hospitalization or pregnancy within 3 months
- Current anticoagulation therapy (within 7 days of enrollment)
- Participation in a clinical study involving a investigational product within 3 months
- Major co-existing disease or clinically significant laboratory abnormalities
- Known allergic response to polidocanol or heparin or severe and/or multiple allergicreactions
- Women of childbearing potential not using effective contraception one month prior toenrollment and/or unwilling to continue while on study
- Pregnant or lactating women
- Current alcohol or drug abuse
Study Design
Total Participants: 77
Study Start date:
October 01, 2008
Estimated Completion Date:
August 31, 2009
Study Description
Connect with a study center
Scottsdale, Arizona 85255
United StatesSite Not Available
New York, New York 10016
United StatesSite Not Available
Charlotte, North Carolina 28207
United StatesSite Not Available
empty
Winston Salem, North Carolina 27157
United StatesSite Not Available
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Bellevue, Washington 98004
United StatesSite Not Available
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