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

Boston Scientific

Status and phase: Terminated; Phase 4

Conditions: Varicose Veins

Treatments: Drug: Varithena®; Device: FDA-approved Endothermal Ablation (ETA) systems

Study type: Interventional

Funder types: Industry

Identifiers

NCT05312970

S2473

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Varithena®

Active Comparator group

Description:

Varithena® (polidocanol injectable foam) 1%

Treatment:

Drug: Varithena®

FDA-approved ETA systems

Active Comparator group

Description:

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

Treatment:

Device: FDA-approved Endothermal Ablation (ETA) systems