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Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

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

NCT05312970•Boston Scientific Corporation

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (9)

Vascular Care Connecticut

Darien, Connecticut, United States

Medstar Georgetown University Hospital

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

Cardiovascular Institute of the South

Houma, Louisiana, United States

Vein Healthcare Center

South Portland, Maine, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

UT Physicians Cardiothoracic and Vascular Surgery

Houston, Texas, United States

Lake Washington Vascular

Bellevue, Washington, United States

Key Dates

Start Date

February 10, 2023

Primary Completion Date

April 4, 2024

Completion Date

April 4, 2024

Last Updated

March 20, 2026

Enrollment

ACTUAL participants

Conditions

Varicose Veins

Interventions

Varithena®

DRUG

FDA-approved Endothermal Ablation (ETA) systems

DEVICE

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

NCT07449728

Varicose VeinsChronic Venous Insufficiency

View study

RECRUITINGPHASE4

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

NCT05735639

Venous ThromboembolismVaricose Veins

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins

Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors

Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Registry for Chronic Venous Disease Incidence and Natural Course