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

Primary Purpose

Varicose Veins

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varithena®
FDA-approved Endothermal Ablation (ETA) systems
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Varicose Veins focused on measuring Great Saphenous Vein Incompetence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vascular Care ConnecticutRecruiting
  • Medstar Georgetown University HospitalRecruiting
  • Cardiovascular Institute of the SouthRecruiting
  • Vein Healthcare CenterRecruiting
  • Englewood Hospital and Medical CenterRecruiting
  • Stony Brook University HospitalRecruiting
  • UT Physicians Cardiothoracic and Vascular SurgeryRecruiting
  • Lake Washington VascularRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Varithena®

FDA-approved ETA systems

Arm Description

Varithena® (polidocanol injectable foam) 1%

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

Outcomes

Primary Outcome Measures

Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
Mean change in Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment

Secondary Outcome Measures

Full Information

First Posted
March 29, 2022
Last Updated
October 18, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05312970
Brief Title
Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
Acronym
VERITAS
Official Title
A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Great Saphenous Vein Incompetence

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial 1:1 assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Varithena®
Arm Type
Active Comparator
Arm Description
Varithena® (polidocanol injectable foam) 1%
Arm Title
FDA-approved ETA systems
Arm Type
Active Comparator
Arm Description
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Intervention Type
Drug
Intervention Name(s)
Varithena®
Intervention Description
Varithena® (polidocanol injectable foam) 1%
Intervention Type
Device
Intervention Name(s)
FDA-approved Endothermal Ablation (ETA) systems
Intervention Description
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Primary Outcome Measure Information:
Title
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
Description
Mean change in Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment
Time Frame
Baseline to 3-month post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Keo
Phone
425.599.3814
Email
Timothy.Keo@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Mensah
Phone
612.403.7653
Email
Sharon.Mensah@bsci.com
Facility Information:
Facility Name
Vascular Care Connecticut
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul J Gagne, MD
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misaki Kiguchi, MD
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Walker, MD
Facility Name
Vein Healthcare Center
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Asbjornsen, DO
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Elias, MD
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonios P Gasparis, MD
Facility Name
UT Physicians Cardiothoracic and Vascular Surgery
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Harlin, MD
Facility Name
Lake Washington Vascular
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Gibson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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