Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 5
- 主要终点
- Vascular closure rate at 6 months after the operation
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the treatment of varicose veins.
详细描述
In this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (Hongyuan Endovenous Radiofrequency Ablation Closure System)and control group (Medtronic's ClosureFast™ Radiofrequency Ablation System) at 1:1. The effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old, no gender limit.
- •Great saphenous varicose, CEAP grade C2-C
- •The diameter of the diseased vein is ≥2mm, ≤15mm.
- •Expected survival period ≥ 6 months.
- •The informed consent form can be signed by the patient or the legal representative.
排除标准
- •Are pregnant or breastfeeding.
- •Participating in clinical trials of other devices or drugs.
- •Deep vein thrombosis in the affected limb.
- •Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L).
- •Acute thrombosis in the main saphenous vein of the affected limb.
- •The investigator judged that it is not suitable to participate in the clinical trial.
结局指标
主要结局
Vascular closure rate at 6 months after the operation
时间窗: 6 months
Calculation method: completely closed patients / total cases of subjects in the same group x 100%. Definition of complete closure: Complete closure refers to ultrasound follow-up at 6 months after surgery that shows no blood flow in varicose veins.
次要结局
- Technical success rate(6 months)
- CEAP(6 months)
- Evaluation of the use of devices(6 months)
- VCSS(6 months)