A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Stopped early · Phase 2
Conditions studied: Venous Insufficiency
In brief
VICARES is a prospective randomized, controlled, multi-center, double blind study treating venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium Tetradecyl Sulfate (STS) solution utilizing the ClariVein system.
Key facts
- Study ID
- NCT03311269
- Run by
- Vascular Insights, LLC
- People needed
- 19
- Starts
- 2017-09-22
- Expected to finish
- 2020-03-27
- Last updated by the study team
- 2022-03-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult patient with incompetent saphenous vein
- Saphenous vein reflux > 500ms (0.5s), as measured by duplex ultrasound
- One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.
- Candidate for endovenous procedure
You may not qualify if…
- Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings
- Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) <0.6
- Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity
- Previous surgical or endovenous procedure in the treatment section of the target vein
- Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section
- Pregnant or breastfeeding
- Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)
- Known high risk of thrombosis
- Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of acute superficial vein thrombus, known hypercoagulable condition, post thrombotic syndrome
- Known history of anaphylaxis or presence of multiple severe allergies
Where it is running
- The Vascular Experts — Darien, Connecticut, United States
- Capitol Vein and Laser Centers — Frederick, Maryland, United States
- Southeastern Surgical Associates — Hyannis, Massachusetts, United States
- Englegwood Hospital and Medical Center — Englewood, New Jersey, United States
- Lake Washington Vascular, PLLC — Bellevue, Washington, United States
Full record on ClinicalTrials.gov
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