A Multicenter Prospective Single-arm Study to Evaluate the Safety and Efficacy of a Novel Transcatheter Pulmonary Thrombectomy System Which Named 'TwiFlow' for Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 127
- 主要终点
- Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
研究概览
简要总结
As a multicenter prospective single-arm clinical study, the investigators plan to recruit patients with acute pulmonary intravascular embolization from nationwide multi-center hospital organizations in China. The investigators use the production of transcatheter pulmonary artery bolt system which named 'TwiFlow Thrombectomy Catheter System' developed by the MorningSide (NanTong) medical device Co., LTD. on pulmonary artery interventional therapy to evaluating the efficacy and safety of this novel system in the treatment of patients with pulmonary intravascular embolization disease.
详细描述
As a multicenter prospective single-arm clinical study, the investigators plan to evaluate the new production's efficacy and safety which named 'TwiFlow-Thrombectomy Catheter System'. This study will be carried out in nationwide multi-center hospital organizations in China. According to the statistical principle, the sample size of this study was estimated, and the final number of selected cases was 127. After screening, all subjects will be treated with transcatheter pulmonary artery thrombectomy system, and clinical follow-up will be conducted at 48 hours, 14 days and 30 days after surgery. Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery and the incidence of major adverse events (MAE) within 48 hours after surgery were used as primary endpoints. In instrument performance evaluation, the success rate of surgery, postoperative immediate target lesion embolus removal efficiency, pulmonary artery pressure changes before and after operation value, values of arterial oxygen partial pressure changes before and 14 days after operation, death rates related to the equipment in 48 hours after surgery, incident rate of bleeding in 48 hours after operation, postoperative clinical deterioration rate in 48 hours after surgery, postoperative pulmonary vascular injury incidence in 48 hours after surgery, the incidence of heart damage injury in 48 hours after surgery, all-cause death rate in 30 days after surgery, and symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery were secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ age ≤75, no gender limitation;
- •patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance;
- •RV/LV ratio ≥0.9;
- •Duration of pulmonary embolism symptoms ≤14 days
- •Systolic blood pressure ≥90mmHg
- •Patients who agreed to participate in the study and voluntarily signed the informed consent.
排除标准
- •Target vessel diameter < 6.6mm;
- •Calcification, plaque or stenosis of target lesions;
- •Pulmonary arterial hypertension with peak pulmonary arterial pressure >70mmHg;
- •Vasopressor is required after infusion to maintain pressure ≥90mmHg;
- •Hematocrit < 28%;
- •Patients with left bundle branch block;
- •A history of chronic left heart failure and left ventricular ejection fraction≤30%;
- •Patients with abnormal renal function (serum creatinine > 1.8 mg/dL or >159umol/L);
- •Patients with known coagulopathy or bleeding tendency (platelet<100×109/L, or INR> 3);
- •Patients who cannot receive antiplatelet or anticoagulant therapy;
- •Patients who underwent cardiovascular or pulmonary open surgery within 7 days before surgery;
- •Patients with intracardiac thrombosis;
- •Patients treated with extracorporeal membrane oxygenation;
- •Patients known to be allergic to contrast agents;
- •Patients with diseases that may cause difficulty in treatment and evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate surgery, life expectancy less than 3 months, etc.);
- •Pregnant and lactating women;
- •Patients who are participating in clinical trials of other drugs or medical devices;
- •Other patients deemed unsuitable for the study by the investigator;
结局指标
主要结局
Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
时间窗: before and 48 hours after surgery
Right Ventricular (RV) and Left Ventricular (LV) were recorded during the screening period and 48 hours after surgery by echocardiography or pulmonary artery CT (CTPA), and RV/LV and RV/LV reduction were calculated. The target RV/ LV reduction from baseline to 48 hours after surgery was at least 0.2.
The incidence of major adverse events (MAE) within 48 hours after surgery
时间窗: 48 hours after surgery
The incidence of major adverse events (MAE) during and 48 hours after surgery was observed and recorded, and the incidence of MAE was calculated (referring to the definition of MAE). The target incidence of MAE 48 hours after surgery was less than 25%. MAE events defined as those occurring within 48 hours of treatment include device-related death, massive bleeding, pulmonary vascular injury, and cardiac injury. Haemorrhage: Disabling or life-threatening bleeding, or severe haemodynamic injury. Pulmonary vascular injury: Defined as perforation or injury of a major pulmonary artery branch requiring surgical open surgical intervention. Cardiac injury: Defined as heart injury requiring surgical open surgical intervention.
次要结局
- the success rate of surgery(intraoperative period)
- postoperative clinical deterioration rate in 48 hours after surgery(48 hours after surgery])
- symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery(30 days after surgery)
- instrument performance evaluation(intraoperative period)
- pulmonary artery pressure changes before and after operation value(before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately)
- values of arterial oxygen partial pressure changes before and after operation(before the pulmonary intravascular embolization removal procedure began and 14 days after surgery)
- all-cause death rate in 30 days after surgery(30 days after surgery)