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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 19
- Locations
- 5
- Primary Endpoint
- Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
ClariVein RES 1% Injection
Sodium Tetradecyl Sulfate 1% Injection single administration
Intervention: ClariVein RES (Device)
ClariVein RES 1% Injection
Sodium Tetradecyl Sulfate 1% Injection single administration
Intervention: Sodium Tetradecyl Sulfate 1% Injection (Drug)
ClariVein RES 3% Injection
Sodium Tetradecyl Sulfate 3% Injection single administration
Intervention: ClariVein RES (Device)
ClariVein RES 3% Injection
Sodium Tetradecyl Sulfate 3% Injection single administration
Intervention: Sodium Tetradecyl Sulfate 3% Injection (Drug)
Outcomes
Primary Outcomes
Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.
Time Frame: 12 weeks
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.
Secondary Outcomes
- Elimination of Saphenous Vein Reflux(12 weeks)