Endovenous Radiofrequency Closure Catheter and Endovenous Radiofrequency Closure Generator in the Treatment of Varicose Veins of Lower Extremity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Complete closure rate of great saphenous vein
研究概览
简要总结
The purpose of the RCT trial is to determine whether endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and ClosureRFG™ in treating varicose veins of lower extremity.
详细描述
This trial is a prospective, multi-center, 1:1 randomized using endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator versus ClosureFast™ and ClosureRFG™ to treat varicose veins of lower extremity. And parimary endpoint is Complete closure rate of great saphenous vein at 6 months post-procedure.
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
- Single (Outcomes Assessor)
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
- •18 to 80 years of age
- •Patients clinically diagnosed as primary varicose great saphenous veins of lower extremity. And unilateral superficial varicose veins of lower extremity will be treated in this procedure.
- •Patients with CEAP classification as C2-C
- •Voluntarily participate in this study and sign the informed consent form
排除标准
- •patients with target vein diameter < 2mm or > 15mm.
- •the distance between the anterior wall of the vessel and the skin of the target vein under ultrasound is less than 0.5cm.
- •patients with aneurysmal dilation at the saphenous femoral junction.
- •patients with venous aneurysm (defined as venous hemangioma with a diameter greater than or equal to 2 times the diameter of the adjacent vein).
- •thrombosis or thrombophlebitis in the trunk of great saphenous vein.
- •the great saphenous vein is so tortuous that radiofrequency closure catheter cannot cross the vein trunk.
- •patients with target diseased vessels who have received surgical treatment in the past.
- •patients with deep venous thrombosis or a history of pulmonary embolism.
- •patients with active implants such as pacemakers or ICD.
- •patients with severe hepatic and renal dysfunction (ALT > normal upper limit 3 times; creatinine > 225umol/L).
- •patients who are contraindications to anesthesia.
- •patients with secondary varicose veins caused by deep venous thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome), arteriovenous fistula, etc.
- •any serious or uncontrollable systemic disease (including uncontrolled hypertension, diabetes, active bleeding signs or severe coagulation disorders, etc.).
- •patients with diseases that may cause difficulties in treatment and evaluation (such as malignant tumors, acute infectious diseases, septicemia, general intolerability of surgery, life expectancy less than 12 months, etc.).
- •pregnant and lactating women, or those who had a planned birth during the study period.
- •patients who have participated in clinical trials of other drugs or medical devices in the past 3 months.
- •According to the judgement of the investigator, other situations that are not suitable for enrollment.
结局指标
主要结局
Complete closure rate of great saphenous vein
时间窗: at 6 months post-procedure
Closure is 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. Recanalization is defined as openings along the treated segment exceeding 5 cm in length as detected by duplex ultrasound. Complete closure rate = the number of subjects with closure of target vein in the group / the total number of subjects in the group x100%
次要结局
- venous clinical severity score(at 6 months post-procedure)
- Device success rate(during procedure)
- Immediate technical success rate(during procedure (Instantly after the catheter retrieved))
- Aberdeen Varicose Vein Questionnaire(at 6 months post-procedure)
- Evaluation of the use of devices(during procedure)