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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Pulmonary Embolism
- Sponsor
- Morningside (Nantong) Medical Co.,Ltd
- Enrollment
- 127
- Primary Endpoint
- Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Right Ventricular/Left Ventricular decline from baseline to 48 hours after surgery
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)