Status:
TERMINATED
Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Varicose Veins
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05312970
Start Date
February 10 2023
End Date
April 4 2024
Last Update
September 25 2024
Active Locations (9)
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1
Vascular Care Connecticut
Darien, Connecticut, United States, 06820
2
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20057
3
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
4
Vein Healthcare Center
South Portland, Maine, United States, 04106