A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of a Novel Varicose Vein Closure Adhesive System for the Treatment of Lower Extremity Varicose Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 6
- 主要终点
- The rate of participants with complete GSV closure
研究概览
简要总结
A prospective, multicenter, randomized, controlled, non-inferiority trial in which patients with great saphenous vein varicosities were treated with either the novel vein closure system (Shanghai Tendfo Medical Technology Co., Ltd.) or radiofrequency ablation (RFA).
详细描述
This prospective, multicenter, randomized, controlled, non-inferiority trial will enroll 180 patients with great saphenous vein (GSV) varicosities across multiple qualified centers. Eligible patients who provide informed consent will be randomized 1:1 to receive either the experimental treatment with cyanoacrylate closure (CAC) ( the Varicose Vein Closure Adhesive System, Shanghai Tendfo Medical Technology Co., Ltd.) or the control treatment with radiofrequency ablation (RFA) (the ClosureRFG™ generator and ClosureFast™ catheter, Medtronic Inc.), resulting in 90 patients per group. Enrollment is expected to start in June 2023 and complete by the end of 2023. Follow-up visits will occur before discharge or at 7 days after surgery, and at months 1, 3, 6, and 12, with Doppler ultrasound assessments at months 1, 3, 6, and 12 after surgery.
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 years and ≤ 80 years at the time of screening, no restrictions on gender.
- •Clinical diagnosis of unilateral / bilateral varicose GSV of lower extremities. This operation only deals with unilateral trunk of GSV.
- •CEAP classification of C2 - C4b.
- •Ability to understand the requirements of the study, provide informed consent, and attend follow-up visits.
排除标准
- •Life expectancy <1 year.
- •Patients with vessel diameter < 3mm or > 12mm in the target segment of the GSV.
- •Deep vein thrombosis (DVT) (excluding intermuscular venous thrombosis) or pulmonary embolism (PE).
- •Undergone interventional or surgical treatment of the GSV in the target limb.
- •Allergies to lidocaine or cyanoacrylates.
- •GSV was extreme distorted and thus unsuitable for minimally invasive interventional treatment.
- •Aneurysm of the target vein with local vein diameter >12 mm.
- •Active superficial thrombophlebitis in the target GSV.
- •Pregnant and / or lactating patients.
- •Patients who are participating in clinical trials of other drugs or medical devices.
- •Patients considered ineligible for inclusion by the investigator.
研究组 & 干预措施
CAC
Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.)
干预措施: CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.) (Device)
RFA
the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)
干预措施: RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.) (Device)
结局指标
主要结局
The rate of participants with complete GSV closure
时间窗: 3 months after surgery
Complete closure was defined as Doppler ultrasound examination (including color flow, compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm in length.
次要结局
- AE rates(The day of surgery, before discharge, 7 days, 1 month, 3 months, 6 months and 12 months after surgery)
- Success rate of operation(Immediately after surgery)
- Aberdeen Varicose Vein Questionnaire (AVVQ)(Screening period and 1、3、6、12 months after surgery)
- Ecchymosis evaluation(Before discharge or 7 days after surgery)
- The rate of participants with complete GSV closure(1、6、12 months after surgery)
- Pain score(Before discharge or 7 days after surgery)
- Performance evaluation of the novel vein closure system(During or after surgery)
- CEAP (Clinical - Etiology - Anatomy - Pathophysiology) classification(Screening period and 1、3、6、12 months after surgery)
- Venous Clinical Severity Score (VCSS)(Screening period and 1、3、6、12 months after surgery)