the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of sequelae of deep venous thrombosis after PMT
研究概览
简要总结
This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.
详细描述
Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)；
- •Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ;
- •Obtain the informed consent of all patients.
排除标准
- •Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ;
- •patients who are prohibited from thrombolytic therapy;
- •inferior vena cava compression syndrome；
- •Allergic to heparin, low molecular weight heparin or contrast medium;
- •Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months;
- •Patients who do not want to participate in this trial;
- •Patients with poor compliance, or those who the researchers think are not suitable for selection.
结局指标
主要结局
Incidence of sequelae of deep venous thrombosis after PMT
时间窗: 24 months
According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.
Lower extremity deep vein patency rate 6 months after operation
时间窗: 6 months
The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography.
次要结局
- Lower extremity deep venous patency rate of patients before discharge(1 week)
- Incidence of bleeding complications(1day，7day，3 months)
- Total duration of interventional treatment(1 day)
- Postoperative quality of life score (QOL)(6 months,12 months,18 months and 24 months)
- reoperation rate(6 months,12 months,18 months and 24 months)
- Total urokinase dosage(1 day)
研究者
Chunshui He
the director of the vascular surgery of Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine