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

NCT05312970 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: S2473
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Varicose Veins

Keywords

Great Saphenous Vein Incompetence

Outcome Measures

Primary Outcomes (1)

• Change in Varicose Veins Symptoms Questionnaire (VVSymQ)

  Mean change in points of total score on Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment. VVSymQ scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time.

  Baseline to 3-month post treatment

Study Arms (2)

Varithena®

ACTIVE COMPARATOR

Varithena® (polidocanol injectable foam) 1%

Drug: Varithena®

FDA-approved ETA systems

ACTIVE COMPARATOR

FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

Device: FDA-approved Endothermal Ablation (ETA) systems

Interventions

FDA-approved Endothermal Ablation (ETA) systems DEVICE

FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

FDA-approved ETA systems

Varithena® DRUG

Varithena® (polidocanol injectable foam) 1%

Varithena®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (9)

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Vein Healthcare Center

South Portland, Maine, 04106, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

UT Physicians Cardiothoracic and Vascular Surgery

Houston, Texas, 77030, United States

Location

Lake Washington Vascular

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Varicose Veins

Interventions

Polidocanol; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Limitations and Caveats

Sponsor decided to terminate study early solely due to slow enrollment.

Results Point of Contact

• Title: Timothy Keo
• Organization: Boston Scientific

timothy.keo@bsci.com

4255993814

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial 1:1 assignment

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: February 10, 2023
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)