Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
- Conditions
- Varicose Veins
- Registration Number
- NCT05312970
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria:<br><br> - Age = 18<br><br> - Primary GSV incompetence, defined as reflux > 0.5 seconds on Duplex ultrasound in a<br> single limb (Note the contralateral limb can have varicosities or SVI if<br> intervention is not required within 3 months i.e. asymptomatic)<br><br> - Failed conservative therapy (compression, diet, exercise, leg elevation)<br><br> - CEAP Clinical Condition Classification C2 - C6<br><br> - Vein diameter 5-10mm, inclusive<br><br> - GSV treatable length > 10cm<br><br> - Superficial venous disease manifest by clinical symptoms (rVCSS = 4)<br><br> - Able to comprehend and sign an informed consent document and complete written study<br> questionnaires<br><br> - Willing and able to return for scheduled follow-up visits (7-days, 3-months,<br> 6-months, 12-months, 24-months, and 36-months post-procedure)<br><br> - Willingness to comply with post-treatment compression protocol<br><br>Exclusion Criteria:<br><br> - Allergy to polidocanol, xylocaine, or epinephrine<br><br> - Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or<br> hypercoagulable disorder<br><br> - Post thrombotic deep vein disease above the calf veins<br><br> - Pregnancy or lactating (within 30 days of randomization)<br><br> - Symptomatic peripheral arterial disease or ankle-brachial pressure index (ABPI) <<br> 0.8<br><br> - Previous treatment to targeted incompetent GSV or previous superficial<br> thrombophlebitis in targeted GSV<br><br> - Previous venous intervention in affected limb in past 3 months<br><br> - Local aneurysmal GSV segments<br><br> - Inability to walk unaided<br><br> - Inability to wear post-procedure compression bandaging and stockings<br><br> - Patients with clinically significant reflux of the small saphenous vein (SSV) or<br> anterior accessory saphenous vein (AASV)<br><br> - In the clinical judgement of the investigator, patient who will require ipsilateral<br> deep venous intervention within 3 months following randomized treatment<br><br> - In the clinical judgement of the investigator, patient who will require<br> contralateral venous intervention (superficial or deep) within 3 months following<br> randomized treatment<br><br> - Patient on therapeutic anticoagulants<br><br> - Active malignancy<br><br> - Life expectancy < 2 years<br><br> - Documented COVID-19 infection currently or within 2 months prior to randomization<br><br> - Enrollment in another clinical trial that could confound the endpoint within 3<br> months prior to screening or within 3 months following enrollment
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
- Secondary Outcome Measures
Name Time Method