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

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

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.

Study Overview

• Status: Terminated
• Conditions: Venous Insufficiency
• Intervention / Treatment: Device: ClariVein RES; Drug: Sodium Tetradecyl Sulfate 1% Injection; Drug: Sodium Tetradecyl Sulfate 3% Injection

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • The Vascular Experts
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Capitol Vein and Laser Centers
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Southeastern Surgical Associates
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englegwood Hospital and Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ClariVein RES 1% Injection; Sodium Tetradecyl Sulfate 1% Injection single administration	Device: ClariVein RES; ClariVein system; Drug: Sodium Tetradecyl Sulfate 1% Injection; Sodium Tetradecyl Sulfate STS 1% Injection; Other Names: STS 1%
Active Comparator: ClariVein RES 3% Injection; Sodium Tetradecyl Sulfate 3% Injection single administration	Device: ClariVein RES; ClariVein system; Drug: Sodium Tetradecyl Sulfate 3% Injection; Sodium Tetradecyl Sulfate 3% Injection; Other Names: STS 3%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vascular Insights, LLC
• Investigators: Study Chair: Mark H Meissner, MD, Vascular and Endovascular Surgery Clinic at UWMC

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency; Pharmaceutical Solutions; Sclerosing Solutions; Sodium Tetradecyl Sulfate
• Other Study ID Numbers: CL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes