Clinical trial NCT03311269: A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Venous Insufficiency
Lead sponsor: Vascular Insights, LLC
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.
timeFrame: 12 weeks
Secondary outcomes:
measure: Elimination of Saphenous Vein Reflux
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Darien
country: United States
facility: The Vascular Experts
state: Connecticut
city: Frederick
country: United States
facility: Capitol Vein and Laser Centers
state: Maryland
city: Hyannis
country: United States
facility: Southeastern Surgical Associates
state: Massachusetts
city: Englewood
country: United States
facility: Englegwood Hospital and Medical Center
state: New Jersey
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
Study officials:
affiliation: Vascular and Endovascular Surgery Clinic at UWMC
name: Mark H Meissner, MD
role: STUDY_CHAIR
References: