Last updated: April 19, 2021
Sponsor: Boston Scientific Corporation
Overall Status: Completed
Phase
3
Condition
Varicose Veins
Vascular Diseases
Occlusions
Treatment
N/AClinical Study ID
NCT01197833
VAP.VV017
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 questionnairesin English
Exclusion
Exclusion Criteria:
- Patients who only have telangiectatic or reticular veins (Clinical Finding C1, asassessed by CEAP Classification of Venous Disorders)
- Patients who have active ulceration on the leg to be treated (Clinical Finding C6, asassessed by CEAP Classification of Venous Disorders)
- Leg obesity impairing the ability to access the vein to be treated and/or to applypost-procedure compression bandaging and stockings
- Ultrasonographic or other evidence of current or previous deep vein thrombosis orocclusion
- Deep venous reflux unless clinically insignificant in comparison to superficial reflux
- Peripheral arterial disease precluding the wearing of post-procedure compressionbandaging and stockings
- Reduced mobility
- History of deep vein thrombosis, pulmonary embolism or stroke, including evidence ofprior 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 hepaticinsufficiency; serious skin disease/condition that may compromise the ability of thepatient to comply with the compression protocol, etc.)
- Known allergic response to polidocanol or heparin, including history ofheparin-induced thrombocytopenia, and/or multiple allergic reactions
- Current alcohol or drug abuse
- Pregnant or lactating women
- Women of childbearing potential not using effective contraception
Study Design
Total Participants: 117
Study Start date:
September 01, 2010
Estimated Completion Date:
December 31, 2012
Connect with a study center
Scottsdale, Arizona 85255
United StatesSite Not Available
Bradenton, Florida 34209
United StatesSite Not Available
Oak Brook, Illinois 60523
United StatesSite Not Available
North Tonawanda, New York 14120
United StatesSite Not Available
Stony Brook, New York 11974
United StatesSite Not Available
Charlotte, North Carolina 28207
United StatesSite Not Available
Kirkland, Washington 98034
United StatesSite Not Available
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