Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Valvular reflux prevalence
研究概览
简要总结
To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.
详细描述
All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.
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
- •Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).
排除标准
- •Participants were excluded if they had symptoms for more than 14 days.
研究组 & 干预措施
Pharmacomechanical Catheter-directed Thrombolysis for acute DVT
AngioJet, Boston Scientific
干预措施: AngioJet device (Device)
anticoagulation alone for acute DVT
anticoagulation alone for acute DVT
干预措施: anticoagulation alone (Other)
结局指标
主要结局
Valvular reflux prevalence
时间窗: at 12 months after procedure
Proportion of patients with femoral venous valve reflux at 1 year after procedure
次要结局
- Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)(at 6, 12 and 24 months after procedure)
- Patency rate of femopopliteal vein and iliofemoral vein(at 6, 12 and 24 months after procedure)
研究者
Kaichuang Ye, MD, PhD
Vice professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University