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

Venous Insufficiency Clinical Trial

— VICARES  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03311269
• Other study ID #: CL-001
• Status: Terminated
• Phase: Phase 2
• Start date: September 22, 2017
• Est. completion date: March 27, 2020

Study information

• Verified date: February 2022
• Source: Vascular Insights, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 27, 2020
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• ClariVein RES
ClariVein system

Drug:
• Sodium Tetradecyl Sulfate 1% Injection
Sodium Tetradecyl Sulfate STS 1% Injection
• Sodium Tetradecyl Sulfate 3% Injection
Sodium Tetradecyl Sulfate 3% Injection

Locations

Country	Name	City	State
United States	Lake Washington Vascular, PLLC	Bellevue	Washington
United States	The Vascular Experts	Darien	Connecticut
United States	Englegwood Hospital and Medical Center	Englewood	New Jersey
United States	Capitol Vein and Laser Centers	Frederick	Maryland
United States	Southeastern Surgical Associates	Hyannis	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Insights, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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