High-risk PCI
Conditions
Interventions
Test group:Synflow system
control group:Venoarterial Extracorporeal Membrane Oxygenation,VA-ECMO
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. age: >=18 and <=90 years old, male or female; 2. the investigator assessed that the subject needed coronary revascularization, but there was a high risk of CABG, or the subject refused to accept CABG. The investigator assessed that the subject may benefit from PCI. 3. left ventricular ejection fraction LVEF <=35%. 4. CAG or CTA shows that the coronary artery condition meets any of the following conditions: (1) Only a single open lesion remained (2) Unprotected left main disease (3) Three vessel disease 5. patients who can understand the purpose of this trial, sign the informed consent, have good compliance after discharge, and are willing to accept clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. STEMI within 24 hours; 2. 24-hour cardiac arrest; 3. cardiogenic shock or acute attack of chronic heart failure (decompensated state) (cardiogenic shock: systemic hypotension (systolic blood pressure 90 mmHg) and any of the following: still need cardiac / pressor drugs to maintain or have any clinical evidence of end organ hypoperfusion before entering the catheter room or use IABP or other circulatory AIDS); 4. stroke and TIA attack within one month before operation; 5. contraindications for PVAD and ECMO that cannot be placed or applied (including but not limited to left ventricular mural thrombus, presence of artificial aortic valve or cardiac contractile device, moderate to severe aortic stenosis, moderate to severe aortic regurgitation, serious vascular lesions such as stent, tortuosity and sandwich in peripheral vascular access that hinder the placement of research instruments, aortic dissection, aneurysm or serious abnormalities of ascending aorta and / or aortic arch, blood system diseases with fragile or hemolytic blood cells, hypertrophic obstructive cardiomyopathy, etc.); 6. presence or suspected systemic active infection; 7. known contraindications to heparin (including heparin induced thrombocytopenia), contrast agents or drugs required for the study (such as aspirin, clopidogrel, etc.); 8. there were uncorrectable coagulation abnormalities before operation, including platelet count = 2.0; 9. liver dysfunction: liver enzymes and bilirubin are higher than 3 times the upper limit of normal; 10. renal insufficiency: the subject is on dialysis or blood creatinine >= 4mg/dl (353.6umol/l); 11. severe right heart failure or severe tricuspid regurgitation; 12. women who are pregnant or lactating, or who have pregnancy plans during the trial; 13. those who are participating in clinical trials of other drugs or medical devices before enrollment and fail to reach the primary endpoint; 14. other circumstances that the investigator determines are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence MAE in 30 days after PCI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence MAE in 90 days (± 14 days) after PCI;Incidence of MACCE at 30 days (± 7 days) and 90 days (± 14 days) after PCI;Change in creatinine clearance from baseline to 48h and 30 days (± 7 days) after PCI; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed