NCT04726124Unknown不适用
A Prospective, Multicenter, Randomized, Controlled Clinical Trial to Validate the Safety and Efficacy of Microwave Versus Laser Ablation of the Great Saphenous Vein in Patients With Varicose Veins
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- the complete closure rate of great saphenous vein at 6 months after surgery
研究概览
简要总结
To validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities
详细描述
A prospective, multicenter, randomized, controlled clinical trial to validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities
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
- •Age 18 years or older, not older than 80 years, male or female
- •Patients clinically diagnosed as primary great saphenous vein insufficiency with reflux lasting > 0.5 seconds on duplex ultrasound
- •Patients with CEAP grade C2-C6
- •Patients who voluntarily participate in this trial, understand all the risks and benefits described in the informed consent document, and sign the written informed consent form
排除标准
- •Patients with diameter of target lesion vein < 2 mm or > 15 mm
- •Patients with previous surgical treatment on the target lesion or patients with acute thrombosis
- •Patients with deep vein thrombosis and superficial vein thrombosis
- •Patients with acute systemic infectious diseases
- •Patients with severe liver and kidney dysfunction (ALT > 3 times the upper limit of normal value; creatinine > 225 umol /L)
- •Patients with known uncorrectable bleeding or severe coagulopathy
- •Patients with anesthesia contraindications
- •Patients with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and diabetes mellitus (fasting glucose ≥ 10.0 mmol / L)
- •Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, KT syndrome (Klippel-Trenaunay syndrome), arteriovenous fistula, etc.
- •Patients with other diseases that may cause difficulty in conducting the trial or evaluation, such as mental illness, AIDS, malignant tumors, liver disease, cardiac insufficiency, etc. or patients whose life expectancy is less than 1 year
- •Pregnant, lactating women, or those planning on becoming pregnant during the trial
- •Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months
- •Patients considered unsuitable for inclusion by investigators for other reasons
结局指标
主要结局
the complete closure rate of great saphenous vein at 6 months after surgery
时间窗: 6 months after surgery
Complete closure: Doppler ultrasonography showed that the target vein segment of the entire treatment is closed, with no discontinuous unclosed segment more than 5 cm. Calculation method: Complete closure rate = number of subjects with complete closure of target vein in the group/total number of subjects in the same group × 100%. The B-ultrasound check is performed on subjects 6 months after the surgery for whether the target vein is completely closed, the result is recorded. After the trial is completed, the number of subjects whose target vein is completely closed is counted, and the complete closure rate of great saphenous vein is calculated.
次要结局
- changes of Aberdeen Varicose Vein Questionnaire (AVVQ) score before and after treatment(screening period, 30 days, 3 months, 6 months, 12 months after surgery)
- the complete closure rate of great saphenous vein at 12 months after surgery(12 months after surgery)
- device performance evaluation(during or after surgery)
- surgical success rate(immediately after surgery)
- changes of venous clinical severity score (VCSS) before and after treatment(screening period, 30days, 3 months, 6months, 12 months after surgery)
- time of surgery(immediately after surgery)
研究者
研究点 (1)
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