Pulmonary embolism requiring percutaneous intervention.
Conditions
Interventions
First In Man:Interventional surgery
Confirmatory Clinical Trial:Interventional surgery
Sponsors
Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = age = 80 years old, gender is not limited; 2. The clinical symptoms and signs are consistent with acute pulmonary embolism, and the symptoms related to pulmonary embolism appear for less than 14 days; 3. Pulmonary embolism confirmed by CTPA, RV/LV ratio = 0.9; 4. Subjects or their legal guardians can understand the purpose of the trial, are willing to cooperate with interventional surgery and follow-up, voluntarily participate in the trial and sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Target vessel diameter 3; 5. Serum creatinine > 3.0 mg/dL or > 266 umol/L; 6. Intracardiac lead implanted in the right ventricle or right atrium within 6 months; 7. Received cardiovascular or pulmonary surgery within 7 days before the operation; 8. There is left bundle branch block; 9. History of severe chronic pulmonary hypertension; 10. Severe left ventricular dysfunction; 11. Patients with oxygen-dependent lung underlying diseases; 12. Those who are contraindicated in anticoagulant therapy; 13. Those who are allergic to contrast media; 14. Patients with other serious diseases and expected survival time <3 months; 15. Severe tortuosity, calcification, and stenosis caused by non-thrombosis in vascular access or target lesion vessels; 16. Pregnant or breastfeeding women or those who plan to become pregnant during this trial; 17. Patients who are currently participating in clinical trials of other drugs or medical devices and have not completed the follow-up of the primary endpoint; 18. Other conditions that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between baseline and postoperative 48h RV/LV ratio;The incidence of MAE at 48 hours after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Device success rate;Hospital stay;Postoperative 30-day all-cause mortality;Recurrence rate of symptomatic pulmonary embolism 30 days after operation;Incidence of device-related death within 48 hours after operation;Incidence of pulmonary vascular injury 48 hours after operation;Incidence of cardiac injury 48 hours after operation;The incidence of major bleeding within 48 hours after operation;The incidence of clinical deterioration within 48 hours after operation;The incidence of new arrhythmia within 48 hours after operation;Incidence of device-related adverse events 30 days after operation;Incidence of device-related serious adverse events 30 days after operation;Incidence rate of other adverse events and serious adverse events 30 days after operation;Device defect incidence; | — |
Countries
China
Contacts
Public ContactXinwu Lu
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Outcome results
None listed