Status:
COMPLETED
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Varicose Veins
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 pur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT01231373
Start Date
November 1 2010
End Date
August 1 2014
Last Update
April 21 2021
Active Locations (12)
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1
Dothan, Alabama, United States, 36303
2
San Diego, California, United States, 92120
3
San Diego, California, United States, 92121
4
Lafayette, Indiana, United States, 47905