TerminatedPhase 2

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

Stopped: Study was terminated for administrative reasons

United States19 participantsStarted 2017-09-22

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.

Timeframe: 12 weeks

Trial details

NCT IDNCT03311269

SponsorVascular Insights, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-15

Results submitted2020-05-15

View on ClinicalTrials.gov More Venous Insufficiency trials