A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 9
- 主要终点
- Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Varithena®
Varithena® (polidocanol injectable foam) 1%
干预措施: Varithena® (Drug)
FDA-approved ETA systems
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
干预措施: FDA-approved Endothermal Ablation (ETA) systems (Device)
结局指标
主要结局
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
时间窗: 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.
次要结局
未报告次要终点