Status:
COMPLETED
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Great Saphenous Vein Incompetence
Visible Varicosities
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT01197833
Start Date
September 1 2010
End Date
December 1 2012
Last Update
April 21 2021
Active Locations (7)
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1
Scottsdale, Arizona, United States, 85255
2
Bradenton, Florida, United States, 34209
3
Oak Brook, Illinois, United States, 60523
4
North Tonawanda, New York, United States, 14120