Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
Sponsored by Boston Scientific Corporation
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 3 years ago
What is this trial about?
What are the participation requirements?
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