Varicose Veins
Conditions
Keywords
Great Saphenous Vein Incompetence
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.
Interventions
DRUGVarithena®
Varithena® (polidocanol injectable foam) 1%
DEVICEFDA-approved Endothermal Ablation (ETA) systems
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized controlled trial 1:1 assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Varicose Veins Symptoms Questionnaire (VVSymQ) | Baseline to 3-month post treatment | Mean change in points of total score on Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment. VVSymQ scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time. |
Countries
United States
Participant flow
Pre-assignment details
Of 40 enrolled participants, 40 met inclusion criteria. Study was terminated early, and three participants were screened and met inclusion criteria but did not receive treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 60.2 years STANDARD_DEVIATION 15.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 3 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
None listed