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

NCT03311269 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: CL-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

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.

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Elimination of Saphenous Vein Reflux

  12 weeks

Study Arms (2)

ClariVein RES 1% Injection

ACTIVE COMPARATOR

Sodium Tetradecyl Sulfate 1% Injection single administration

Device: ClariVein RES; Drug: Sodium Tetradecyl Sulfate 1% Injection

ClariVein RES 3% Injection

ACTIVE COMPARATOR

Sodium Tetradecyl Sulfate 3% Injection single administration

Device: ClariVein RES; Drug: Sodium Tetradecyl Sulfate 3% Injection

Interventions

ClariVein RES DEVICE

ClariVein system

ClariVein RES 1% Injection; ClariVein RES 3% Injection

Sodium Tetradecyl Sulfate 1% Injection DRUG

Sodium Tetradecyl Sulfate STS 1% Injection

Also known as: STS 1%

ClariVein RES 1% Injection

Sodium Tetradecyl Sulfate 3% Injection DRUG

Sodium Tetradecyl Sulfate 3% Injection

Also known as: STS 3%

ClariVein RES 3% Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Insights, LLC: lead

Study Sites (5)

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

Capitol Vein and Laser Centers

Frederick, Maryland, 21702, United States

Location

Southeastern Surgical Associates

Hyannis, Massachusetts, 02601, United States

Location

Englegwood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Sodium Tetradecyl Sulfate; Injections; 3-methoxy-14,15-methyleneestra-1,3,5-triene-17-ol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

A total of 19 subjects were enrolled in the study. The study was terminated for administrative reasons; there were no safety or efficacy concerns. It was determined by the sponsor that the Phase 3 protocol, which is designed to closely mimic the Phase 2 protocol, would be adequate to collect safety and efficacy assessments with minor adjustments.

Results Point of Contact

• Title: Ms. Lorraine Hanley, MBA
• Organization: Vascular Inisights, LLC

lorraine.hanley@merit.com

617-519-1109

Study Officials

• Mark H Meissner, MD

  Vascular and Endovascular Surgery Clinic at UWMC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: September 22, 2017
• Primary Completion: May 15, 2018
• Study Completion: March 27, 2020
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)