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

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation
• Treatments: Polidocanol

Criteria

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 (VCSS ≥ 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