Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (NCT05312970) | Clinical Trial Compass
TerminatedPhase 4
Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
Stopped: Enrollment challenges and a difficult insurance coverage landscape
United States43 participantsStarted 2023-02-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 bandagin…
What they're measuring
1
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)