A Clinical Trial to Evaluate the Efficacy and Safety of TwiFlow-System for Acute Pulmonary Embolism

Study Overview
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Brief Summary
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For a prospective, single-arm clinical study, this study plans to recruit patients with acute pulmonary intravascular embolization, use 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, for evaluating the efficacy and safety of this novel system in the treatment of patients with pulmonary intravascular embolization disease.

Detailed Description
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As a 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 Xiamen Cardiovascular Hospital, Xiamen University. A total of 3 subjects are planned to be enrolled. 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 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.

Official Title
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An Exploratory Study to Evaluate the Safety and Efficacy of a Novel Transcatheter Pulmonary Thrombectomy System Which Named 'TwiFlow' for Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: TwiFlow-Thrombectomy Catheter System


Participation Criteria
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Eligibility Criteria
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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; 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; Hematocrit < 28%; Patients with a history of chronic pulmonary hypertension; 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 >159 umol/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 one year, 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>The arm contains patients with acute pulmonary embolism who undergoing interventional therapy with transcatheter pulmonary embolectomy system which named 'TwiFlow-Thrombectomy Catheter System' | Device: TwiFlow-Thrombectomy Catheter System<br>* Patients with acute pulmonary embolism and meeting the conditions of this clinical trial will accept the pulmonary embolism removal operation by the novel device named 'TwiFlow-Thrombectomy Catheter System'.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Ventricular/Left Ventricular decline from baseline to 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 | before and 48 hours after surgery | 
| The incidence of major adverse events (MAE) within 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. | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| instrument performance evaluation | Whether the plug remover is delivered to the specified location or not, whether the thrombectomy stent was successfully deployed or not, whether the plug is retracted successfully or not, whether the thrombectomy device safely removed from the body or not. Whether the conveying system delivers to the specified location or not, whether the delivery system safely removed from the body or not. | intraoperative period | 
| the success rate of surgery | Surgical success was defined as successful thrombectomy without MAE. | intraoperative period | 
| postoperative immediate target lesion embolus removal efficiency | Thrombus clearance = (postoperative target vascular diameter - preoperative target vascular diameter)/preoperative target vascular diameter x100%. The thrombus clearance rate of target lesions can be divided into three grades: <50%, 50-90% and > 90% respectively, in which the thrombus clearance rate ≥50% is effective. | before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately | 
| pulmonary artery pressure changes before and after operation value | Changes in pulmonary artery pressure before and after operation = postoperative pulmonary artery pressure - preoperative pulmonary artery pressure | 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 | Preoperative and postoperative arterial oxygen partial pressure = postoperative arterial oxygen partial pressure - preoperative arterial oxygen partial pressure | before the pulmonary intravascular embolization removal procedure began and after the embolization removal operation end immediately | 
| death rates related to the equipment in 48 hours after surgery | death rates | 48 hours after surgery | 
| incident rate of bleeding in 48 hours after operation | incident rate of bleeding | 48 hours after surgery | 
| postoperative clinical deterioration rate in 48 hours after surgery | Clinical deterioration include instrumentation related events such as unplanned endotracheal intubation, mechanical ventilation, arterial hypotension (>1 hour) or shock, cardiopulmonary resuscitation, significant deterioration of oxygenation, and emergency surgical embolectomy | 48 hours after surgery | 
| postoperative pulmonary vascular injury incidence in 48 hours after surgery | Pulmonary vascular injury: Defined as perforation or injury of a major pulmonary artery branch requiring surgical open surgical intervention. | 48 hours after surgery | 
| the incidence of heart damage injury in 48 hours after surgery | Cardiac injury: Defined as heart injury requiring surgical open surgical intervention. | 48 hours after surgery | 
| all-cause death rate in 30 days after surgery | all-cause death | 30 days after surgery | 
| symptomatic Pulmonary Embolization recurrence rate in 30 days after surgery | patients present with pulmonary embolism again | 30 days after surgery |