Clinical Study On The Improvement Of Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb By Primary Popliteal Vein Thrombosis Clearance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Incidence of post-thrombotic syndrome (PTS)
研究概览
简要总结
Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).
详细描述
Acute deep venous thrombosis (DVT) with whole lower limb involved is associated with significant post thrombotic morbidity. Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, ipsilateral popliteal venous the most common access for PMT. However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein. So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.
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 between 18-80 years old;
- •Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease;
- •DVT with thrombosis involving the iliac vein, common femoral vein, distal popliteal vein, and/or calf vein;
- •Informed consent signed by patients.
排除标准
- •Patients with the previous history of the same side of lower-limb DVT;
- •Patients with plasma Creatinine level greater than 180umol/L;
- •Patients who are contraindicated to thrombolysis;
- •Patients with inferior vena cava thrombosis;
- •Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
- •Patients who have participated in a clinical trial in the past three months;
- •Women during pregnancy and lactation
- •Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<2 years);
- •Patients with autoimmune thrombopathy or thrombocytopenia (platelets < 80·10⁹/L);
- •Patients who are unable or unwilling to participate in the study.
结局指标
主要结局
Incidence of post-thrombotic syndrome (PTS)
时间窗: 24 months
Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months
次要结局
- Immediate patency rate(immediately after lonely mechanical thrombectomy)
- Patency rate of lower limb vein(post-interventional 12 and 24 months)
- European quality of life 5-dimension 5-level (EQ-5D-5L) score(post-interventional 3, 6, 12 and 24 months)
- Total time of interventional surgery(immediately after interventional surgery)
- Total dosage of urokinase(immediately after interventional surgery)
- Deep venous valve function evaluation(post-interventional 12 and 24 months)
- Quality of life evaluated by 36-Item Short Form Health Survey (SF-36)(post-interventional 3, 6, 12 and 24 months)
- Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score(post-interventional 3, 6, 12 and 24 months)
- Re-intervention rate(within 24 months after operation)
- Rate of catheter-directed thrombolysis(immediately after interventional surgery)