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

NCT ID: NCT05312970

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2024-04-04

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.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Varithena®

Varithena® (polidocanol injectable foam) 1%

Group Type: ACTIVE_COMPARATOR

Varithena®

Intervention Type: DRUG

Varithena® (polidocanol injectable foam) 1%

FDA-approved ETA systems

FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

Group Type: ACTIVE_COMPARATOR

FDA-approved Endothermal Ablation (ETA) systems

Intervention Type: DEVICE

FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

Interventions

Varithena®

Varithena® (polidocanol injectable foam) 1%

Intervention Type: DRUG

FDA-approved Endothermal Ablation (ETA) systems

FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vascular Care Connecticut

Darien, Connecticut, United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Vein Healthcare Center

South Portland, Maine, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

UT Physicians Cardiothoracic and Vascular Surgery

Houston, Texas, United States

Lake Washington Vascular

Bellevue, Washington, United States

Countries

United States

Other Identifiers

S2473

Identifier Type: -

Identifier Source: org_study_id