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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Device: ClariVein RES
* Drug: Sodium Tetradecyl Sulfate 1% Injection
* Drug: Sodium Tetradecyl Sulfate 3% Injection


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ClariVein RES 1% Injection<br>Sodium Tetradecyl Sulfate 1% Injection single administration | Device: ClariVein RES<br>* ClariVein system<br>Drug: Sodium Tetradecyl Sulfate 1% Injection<br>* Sodium Tetradecyl Sulfate STS 1% Injection<br>* Other names: STS 1%;|
| Active Comparator: ClariVein RES 3% Injection<br>Sodium Tetradecyl Sulfate 3% Injection single administration | Device: ClariVein RES<br>* ClariVein system<br>Drug: Sodium Tetradecyl Sulfate 3% Injection<br>* Sodium Tetradecyl Sulfate 3% Injection<br>* Other names: STS 3%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms. | The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, & a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination of Saphenous Vein Reflux | Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein > 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow > 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux | 12 weeks |