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

Stopped early · Phase 4

Conditions studied: Varicose Veins

In brief

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.

Key facts

Study ID

NCT05312970

Run by

Boston Scientific Corporation

People needed

43

Starts

2023-02-10

Expected to finish

2024-04-04

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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