None
Conditions
Interventions
Control Group:Extracorporeal Membrane Oxygenation, ECMO
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 90 years old; 2. The subject has at least one lesion (including native lesions and restenosis lesions) in the coronary artery or graft vessel and is planning to undergo PCI surgery; 3. The subject's disease condition must meet either a or b below: (1) Ejection fraction (EF) = 50% through coronary angiography, or complete occlusion. If the coronary artery is left-dominant, lesions in the proximal LAD and LCX can also be defined as triple-vessel disease.) 4. Voluntarily participates and signs the informed consent form, and is able to complete the entire trial process.
Exclusion criteria
Exclusion criteria: 1. Acute ST-segment elevation myocardial infarction (STEMI) within 24 hours or CK-MB levels of acute STEMI patients not yet returned to the normal reference range; 2. Patients who experienced cardiac arrest within 24 hours before surgery and require CPR; 3. Subjects with cardiogenic shock, defined as: (1) Cardiac index (CI) 15 mmHg; (2) Hypotension (systolic blood pressure = 90 mmHg) accompanied by inadequate end-organ perfusion (urine output 60 bpm, or cold and clammy extremities); 4. Left ventricular thrombus; 5. History of aortic valve replacement or presence of mechanical circulatory support device implantation; 6. Complicated by mechanical complications of myocardial infarction; 7. Severe aortic stenosis, stenosis grade >= 2, corresponding to valve area = grade 2; 10. Severe peripheral vascular disease with no suitable device access pathway; 11. Aortic lesions that severely impede surgery, including aortic aneurysm, aortic dissection, severely twisted or calcified aorta; 12. Renal failure (serum creatinine >= 265 µmol/L); 13. Liver dysfunction (transaminase and bilirubin >= 3 times the upper limit of normal (ULN) or INR >= 2); 14. Uncorrectable coagulation disorders (platelet count = 2); 15. History of stroke or TIA within 1 month; 16. Severe right heart dysfunction, such as severe pulmonary hypertension; 17. Known allergy or intolerance to iodinated contrast agents, heparin, aspirin, or ADP receptor inhibitors; 18. History of heparin-induced thrombocytopenia (HIT); 19. Atrial or ventricular septal defects (including post-infarction ventricular septal defects); 20. Pregnant or breastfeeding women; 21. Currently participating in other drug/device clinical trials and have not reached the primary endpoint; 22. Considered by the investigator as unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from MACCE at 30 days post-procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of MACCE at 30 days and 90 days post-procedure;Incidence of Major Adverse Events (MAE) at 30 days and 90 days post-procedure;;Change in NYHA functional class from baseline at 30 days and 90 days post-procedure;;Change in left ventricular ejection fraction (LVEF) from baseline at 30 days and 90 days post-procedure;;Change in echocardiography findings (structural damage) from baseline at 30 days and 90 days post-procedure;;Change in creatinine clearance from baseline at 24 hours post-PCI;;Rate of device performance meeting the target;;Device assessment;;Rate of successful vascular closure on the first attempt.; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed