TwiFlow Thrombectomy Catheter sYstem for Acute Pulmonary Embolism (Twi-TYPE Study) (Twi-TYPE)
Acute Pulmonary Embolism
About this trial
This is an interventional treatment trial for Acute Pulmonary Embolism
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; 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;
Sites / Locations
Arms of the Study
Arm 1
Experimental
treatment group
The arm contains patients with acute pulmonary embolism who undergoing interventional therapy with transcatheter pulmonary embolectomy system which named 'TwiFlow-Thrombectomy Catheter System'