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

Primary Purpose

Venous Insufficiency

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ClariVein RES
Sodium Tetradecyl Sulfate 1% Injection
Sodium Tetradecyl Sulfate 3% Injection
Sponsored by
Vascular Insights, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Vascular Experts
  • Capitol Vein and Laser Centers
  • Southeastern Surgical Associates
  • Englegwood Hospital and Medical Center
  • Lake Washington Vascular, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ClariVein RES 1% Injection

ClariVein RES 3% Injection

Arm Description

Sodium Tetradecyl Sulfate 1% Injection single administration

Sodium Tetradecyl Sulfate 3% Injection single administration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2017
Last Updated
February 9, 2022
Sponsor
Vascular Insights, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03311269
Brief Title
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated for administrative reasons
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Insights, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ClariVein RES 1% Injection
Arm Type
Active Comparator
Arm Description
Sodium Tetradecyl Sulfate 1% Injection single administration
Arm Title
ClariVein RES 3% Injection
Arm Type
Active Comparator
Arm Description
Sodium Tetradecyl Sulfate 3% Injection single administration
Intervention Type
Device
Intervention Name(s)
ClariVein RES
Intervention Description
ClariVein system
Intervention Type
Drug
Intervention Name(s)
Sodium Tetradecyl Sulfate 1% Injection
Other Intervention Name(s)
STS 1%
Intervention Description
Sodium Tetradecyl Sulfate STS 1% Injection
Intervention Type
Drug
Intervention Name(s)
Sodium Tetradecyl Sulfate 3% Injection
Other Intervention Name(s)
STS 3%
Intervention Description
Sodium Tetradecyl Sulfate 3% Injection
Primary Outcome Measure Information:
Title
Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Elimination of Saphenous Vein Reflux
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark H Meissner, MD
Organizational Affiliation
Vascular and Endovascular Surgery Clinic at UWMC
Official's Role
Study Chair
Facility Information:
Facility Name
The Vascular Experts
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Capitol Vein and Laser Centers
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Southeastern Surgical Associates
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Englegwood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Lake Washington Vascular, PLLC
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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