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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein

Conditions
-----------------
Varicose Veins

Intervention / Treatment
-----------------
* Drug: Varithena®
* Device: FDA-approved Endothermal Ablation (ETA) systems


Participation Criteria
=================
Eligibility 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 (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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial 1:1 assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Varithena®<br>Varithena® (polidocanol injectable foam) 1% | Drug: Varithena®<br>* Varithena® (polidocanol injectable foam) 1%<br>|
| Active Comparator: FDA-approved ETA systems<br>FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems. | Device: FDA-approved Endothermal Ablation (ETA) systems<br>* FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Varicose Veins Symptoms Questionnaire (VVSymQ) | Mean change in Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment | Baseline to 3-month post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Great Saphenous Vein Incompetence