Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Incidence of post-thrombotic syndrome
研究概览
简要总结
The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.
详细描述
Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-85 years old;
- •Acute DVT occurred no more than 14 days since the onset of disease;
- •DVT treated by percutaneous mechanical thrombectomy
- •Informed consent signed by patients.
排除标准
- •Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
- •Women during pregnancy and lactation;
- •Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);
- •Patients who are unable or unwilling to participate in the study.
研究组 & 干预措施
Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access
Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access.
干预措施: Percutaneous mechanical thrombectomy (PMT) by the modified approach (Procedure)
Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access
Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral popliteal venous access.
干预措施: Percutaneous mechanical thrombectomy (PMT) by the traditional approach (Procedure)
Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT
Anterograde venography shows patients with iliofemoral DVT without distal popliteal vein thrombosis. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access.
干预措施: Traditional approach (Procedure)
结局指标
主要结局
Incidence of post-thrombotic syndrome
时间窗: 24-month
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
次要结局
- Patency rate of lower limb vein(24-month)
- Rate of catheter-directed thrombolysis(Immediately after interventional surgery)
- Total dosage of urokinase(Immediately after interventional surgery)
- Incidence of post-thrombotic syndrome(12-month)
- Re-intervention rate(24-month)
- Total time of interventional surgery(Immediately after interventional surgery)