Pulmonary embolism
Conditions
Interventions
Experimental group:Use of test products pulmonary vascular embolectomy stent and peripheral aspiration catheter
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old gender is not limited; 2. Patients with acute pulmonary embolism (PE) who need pulmonary thrombosis clearance; 3. Patients with RV/LV >= 0.9; 4. Patients who agreed to participate in this study and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with systolic blood pressure = 90 mmHg; 2. Patients with chronic pulmonary hypertension or preoperative peak pulmonary systolic pressure > 70 mmHg; 3. Patients with hematocrit 1.8 mg/dL or > 159 umol/L); 7. Patients with known coagulation function or tendency (platelet 3); 8. Patients who cannot be treated with antiplatelet or anticoagulant therapy; 9. Patients who underwent cardiovascular or pulmonary surgery within 7 days before operation; 10. Patients with intracardiac thrombosis; 11. Patients treated with extracorporeal membrane oxygenation; 12. Patients who are known to be allergic to contrast media; 13. Patients with diseases that may cause difficulties in treatment and evaluation (such as malignant tumor, acute infectious disease, septicemia, general condition, intolerance to surgery, life expectancy less than 1 year, etc.); 14. Pregnant and lactating women; 15. Patients who are participating in clinical trials of other drugs or medical devices; 16. Other patients who researchers think are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease of RV/LV from baseline to 48h after operation;Incidence of major adverse events (MAE) within 48 hours after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Apparatus success rate;Success rate of operation;Effective rate of thrombus clearance immediately after operation;Changes of pulmonary artery systolic pressure before and after operation;Incidence of instrument-related death 48 hours after operation;Severe incidence 48 hours after operation;Incidence of clinical deterioration 48 hours after operation;Incidence of pulmonary vascular injury 48 hours after operation;Incidence of cardiac injury 48 hours after operation;Incidence of all-cause death at 30 days after operation;Recurrence rate of symptomatic PE 30 days after operation;Incidence of device-related adverse events and serious adverse events 30 days after operation; | — |
Countries
China
Contacts
Public ContactXinwei Han
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed