Acute Pulmonary Embolism
Conditions
Interventions
Experimental Group:Percutaneous Interventional Pulmonary Artery Mechanical Thrombectomy
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects participating in this clinical trial must meet all of the following criteria: (1) Age between 18 and 80 years, regardless of gender; (2) Duration of pulmonary embolism symptoms = 14 days, clinically diagnosed as acute pulmonary embolism (APE), with imaging evidence showing at least one main pulmonary artery or proximal filling defect in the lobar artery; (3) Patients with right ventricular diameter/left ventricular diameter (RV/LV) = 0.9; (4) Patients who agree to participate in this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria cannot be included in this study: (1) The investigator believes that imaging evidence or other evidence indicates that the subject is not suitable for mechanical thrombectomy intervention (e.g., unable to navigate to the target position, thrombus limited to segmental/subsegmental, mainly chronic embolism); (2) Patients with cardiac arrest, obstructive shock (systolic blood pressure 15min, excluding new arrhythmias, hypovolemia, or sepsis); (3) Patients with current or past history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED); (4) If clinically suspected recurrent acute pulmonary embolism in chronic thromboembolic pulmonary hypertension (CTEPH), echocardiographic screening estimated pulmonary artery systolic pressure >70 mmHg; (5) Target vessel diameter 3 times the upper limit of normal (ULN)) or abnormal renal function (glomerular filtration rate 30 L/min); (16) Patients with a history of heparin-induced thrombocytopenia (HIT); (17) Patients with right atrial, right ventricular, inferior vena cava, or other surgical approach thrombi; (18) Patients with known allergies to contrast agents or nickel-titanium alloy materials, or those who cannot tolerate contrast agents; (19) Patients with advanced malignancies, acute severe infectious diseases, sepsis, general condition unable to tolerate surgery, life expectancy less than 90 days, or other conditions that may cause difficulties in treatment and evaluation; (20) Women who plan to become pregnant, are currently pregnant, or are breastfeeding during the study period; (21) Patients who are currently participating in other drug or medical device clinical trials; (22) Patients whom the investigator deems unsuitable for participation in this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease in the right ventricle/left ventricle (RV/LV) ratio from baseline to 48 hours post-surgery;The incidence of major adverse events (MAE) within 48 hours post-surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Surgical success rate;Change in pulmonary artery systolic pressure before and after the procedure;Hospitalization time;Mortality rate related to the device within 48 hours post-operation;Incidence of severe bleeding within 48 hours post-operation;Incidence of clinical deterioration within 48 hours post-operation;Incidence of pulmonary vascular injury within 48 hours post-operation; Incidence of cardiac injury within 48 hours post-operation;All-cause mortality rate within 30 days post-operation;Recurrence rate of symptomatic pulmonary embolism within 30 days post-operation;Incidence rate (%) and frequency (number of events) of adverse events;Incidence rate (%) and frequency (number of events) of serious adverse events; Incidence rate (%) and frequency (number of events) of device-related adverse events;Incidence rate (%) and frequency (number of events) of serious adverse events related to the device; Incidence rate (%) and frequency (number of events) of device defects; | — |
Countries
China
Contacts
Public ContactXin Li, Zhicheng Jing
Guangdong Provincial People's Hospital
Outcome results
None listed