A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency

A Prospective, Randomized, Controlled, Multi-Center, Double Blind Study of ClariVein RES for Treatment of Venous Insufficiency Associated With Incompetent Saphenous Veins Due to Superficial Venous Reflux

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.

Approximately 50 subjects diagnosed with an incompetent saphenous vein will be randomized to either 1% STS or 3% STS solution delivered by the ClariVein system under ultrasound guidance.

Study duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.

Inclusion Criteria:

1. Adult patient with incompetent saphenous vein
2. Saphenous vein reflux > 500ms (0.5s), as measured by duplex ultrasound
3. One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.
4. Candidate for endovenous procedure

Exclusion Criteria:

1. Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings
2. Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) <0.6
3. Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity
4. Previous surgical or endovenous procedure in the treatment section of the target vein
5. Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section
6. Pregnant or breastfeeding
7. Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)
8. Known high risk of thrombosis
9. Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of acute superficial vein thrombus, known hypercoagulable condition, post thrombotic syndrome
10. Known history of anaphylaxis or presence of multiple severe allergies