Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (VERITAS)

A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein

The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Drug: Varithena®; Device: FDA-approved Endothermal Ablation (ETA) systems

Detailed Description

To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Timothy Keo; Phone Number: 425.599.3814; Email: Timothy.Keo@bsci.com
• Study Contact Backup: Name: Sharon Mensah; Phone Number: 612.403.7653; Email: Sharon.Mensah@bsci.com

Study Locations

• United States
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • Recruiting
      • Vascular Care Connecticut
      • Contact: Paul J Gagne, MD
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Recruiting
      • MedStar Georgetown University Hospital
      • Contact: Misaki Kiguchi, MD
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Recruiting
      • Cardiovascular Institute of the South
      • Contact: Craig Walker, MD
  • Maine
    • South Portland, Maine, United States, 04106
      • Recruiting
      • Vein Healthcare Center
      • Contact: Cindy Asbjornsen, DO
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Recruiting
      • Englewood Hospital and Medical Center
      • Contact: Steven Elias, MD
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Contact: Danielle R Bajakian, MD
    • Stony Brook, New York, United States, 11794
      • Suspended
      • Stony Brook University Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • UT Physicians Cardiothoracic and Vascular Surgery
      • Contact: Stuart Harlin, MD
  • Washington
    • Bellevue, Washington, United States, 98004
      • Recruiting
      • Lake Washington Vascular
      • Contact: Kathleen Gibson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• Primary GSV incompetence, defined as reflux > 0.5 seconds on Duplex ultrasound in a single limb (Note the contralateral limb can have varicosities or SVI if intervention is not required within 3 months i.e. asymptomatic)
• Failed conservative therapy (compression, diet, exercise, leg elevation)
• CEAP Clinical Condition Classification C2 - C6
• Vein diameter 5-10mm, inclusive
• GSV treatable length > 10cm
• Superficial venous disease manifest by clinical symptoms (rVCSS ≥ 4)
• Able to comprehend and sign an informed consent document and complete written study questionnaires
• Willing and able to return for scheduled follow-up visits (7-days, 3-months, 6-months, 12-months, 24-months, and 36-months post-procedure)
• Willingness to comply with post-treatment compression protocol

Exclusion Criteria:

• Allergy to polidocanol, xylocaine, or epinephrine
• Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or hypercoagulable disorder
• Post thrombotic deep vein disease above the calf veins
• Pregnancy or lactating (within 30 days of randomization)
• Symptomatic peripheral arterial disease or ankle-brachial pressure index (ABPI) < 0.8
• Previous treatment to targeted incompetent GSV or previous superficial thrombophlebitis in targeted GSV
• Previous venous intervention in affected limb in past 3 months
• Local aneurysmal GSV segments
• Inability to walk unaided
• Inability to wear post-procedure compression bandaging and stockings
• Patients with clinically significant reflux of the small saphenous vein (SSV) or anterior accessory saphenous vein (AASV)
• In the clinical judgement of the investigator, patient who will require ipsilateral deep venous intervention within 3 months following randomized treatment
• In the clinical judgement of the investigator, patient who will require contralateral venous intervention (superficial or deep) within 3 months following randomized treatment
• Patient on therapeutic anticoagulants
• Active malignancy
• Life expectancy < 2 years
• Documented COVID-19 infection currently or within 2 months prior to randomization
• Enrollment in another clinical trial that could confound the endpoint within 3 months prior to screening or within 3 months following enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Varithena®; Varithena® (polidocanol injectable foam) 1%	Drug: Varithena®; Varithena® (polidocanol injectable foam) 1%
Active Comparator: FDA-approved ETA systems; FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.	Device: FDA-approved Endothermal Ablation (ETA) systems; FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)	Mean change in Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment	Baseline to 3-month post treatment

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Great Saphenous Vein Incompetence
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: S2473

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
• product manufactured in and exported from the U.S.: No