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

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ClinicalTrials.gov Identifier: NCT03311269
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Vascular Insights, LLC

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.

Condition or disease Intervention/treatment Phase
Venous Insufficiency Device: ClariVein RES Drug: Sodium Tetradecyl Sulfate 1% Injection Drug: Sodium Tetradecyl Sulfate 3% Injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: STS 3%




Primary Outcome Measures :
  1. Patient-Reported Symptoms [ Time Frame: 12 weeks ]
    Improvement in patient reported symptoms using subset of the VEINES QOL/Sym Questionnaire at post treatment Week 12 compared to Baseline.


Secondary Outcome Measures :
  1. Elimination of saphenous vein reflux [ Time Frame: 12 weeks ]
    As demonstrated by duplex ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311269


Contacts
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Contact: Lorraine M Hanley, MBA 203-446-4953 lhanley@vasularinsights.com
Contact: Nannette R Hayes, BS 203-446-4953 nannette@mccormicklifescience.com

Locations
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United States, Connecticut
The Vascular Experts Recruiting
Darien, Connecticut, United States, 06820
Contact: Maria Myslinksi    203-956-6800    mmyslinski@thevascularexperts.com   
Contact: Lisa Obermayer       lobermayer@thevascularexperts.com   
Principal Investigator: Paul J Gagne, MD         
United States, Maryland
Capitol Vein and Laser Centers Recruiting
Frederick, Maryland, United States, 21702
Contact: Tamara Wilkinson, RN    301-695-8346      
Principal Investigator: Paul McNeill, MD         
Sub-Investigator: Garth Rosenberg, MD         
United States, Massachusetts
Southeastern Surgical Associates Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Donna Potter    508-775-1984    donnamariepotter724@yahoo.com   
Principal Investigator: Daniel Gorin, MD         
Sub-Investigator: Donna Potter         
Sub-Investigator: Lisa Goodwin         
Sub-Investigator: Emily Learned         
Sub-Investigator: Vanessa Peters         
United States, New Jersey
Englegwood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Renee Lockwood    201-894-3852    "Renee.Lockwood@ehmc.com" <Renee.Lockwood@ehmc.com>;   
Principal Investigator: Steven Elias, MD         
United States, Washington
Lake Washington Vascular, PLLC Recruiting
Bellevue, Washington, United States, 98004
Contact: Krissa Gunderson    425-453-1772    krissag@lkwv.com   
Principal Investigator: Kathleen Gibson, MD         
Sub-Investigator: Brian Ferris, MD         
Sub-Investigator: Renee Minjarez, MD         
Sub-Investigator: Krissa Gunderson, CRC         
Sub-Investigator: Irina Stipek, CRC         
Sponsors and Collaborators
Vascular Insights, LLC
Investigators
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Study Chair: Mark H Meissner, MD Vascular and Endovascular Surgery Clinic at UWMC
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Responsible Party: Vascular Insights, LLC
ClinicalTrials.gov Identifier: NCT03311269    
Other Study ID Numbers: CL-001
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases
Sodium Tetradecyl Sulfate
Sclerosing Solutions
Pharmaceutical Solutions