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

Varicose Veins Clinical Trial

— VERITAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05312970
• Other study ID #: S2473
• Status: Terminated
• Phase: Phase 4
• Start date: February 10, 2023
• Est. completion date: April 4, 2024

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Drug:
• Varithena®
Varithena® (polidocanol injectable foam) 1%

Device:
• FDA-approved Endothermal Ablation (ETA) systems
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

Locations

Country	Name	City	State
United States	Lake Washington Vascular	Bellevue	Washington
United States	Vascular Care Connecticut	Darien	Connecticut
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	UT Physicians Cardiothoracic and Vascular Surgery	Houston	Texas
United States	Columbia University Medical Center	New York	New York
United States	Vein Healthcare Center	South Portland	Maine
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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