Clinical trial NCT05312970: Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
Official title: A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Varicose Veins
Keywords: Great Saphenous Vein Incompetence
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial 1:1 assignment
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
timeFrame: Baseline to 3-month post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Darien
country: United States
facility: Vascular Care Connecticut
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: South Portland
country: United States
facility: Vein Healthcare Center
state: Maine
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Houston
country: United States
facility: UT Physicians Cardiothoracic and Vascular Surgery
state: Texas
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
Study officials:
References: