High-risk PCI
Conditions
Interventions
Synflow system:Synflow system
control group:IABP
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 patient has stable hemodynamics and is at high risk of elective or limited duration (non-emergency) PCI requiring hemodynamic support during surgery 3. Willing to participate in the experiment and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. STEMI within 24 hours; 2. Cardiac arrest within 24 hours; 3. Aortic valve disease that the instrument may not be able to pass, such as moderate to severe aortic stenosis; 4. Moderate to severe aortic regurgitation; 5. Previous history of aortic valve replacement or reconstruction surgery; 6. Left ventricular mural thrombus; 7. Aortic disease or abnormality that interferes with surgery, including but not limited to aortic dissection, aneurysm, and extreme distortion or calcification; 8. There is serious peripheral vascular disease that prevents the placement of the test product, such as severe curvature, stenosis or extensive atherosclerotic lesions of the iliac/femoral artery; 9. Had stroke and TIA within one month before enrollment; 10.Cardiogenic shock or acute onset of chronic heart failure(decompensated state)(cardiogenic shock: systemic hypotension<90 mmHg or Cardiotonic/pressor drugs or Any clinical evidence of end-organ hypoperfusion or mechenical support device) 11.Systemic active infection; 12.Contraindications for heparin (including heparin-induced thrombocytopenia), contrast agents, or investigational drugs (e.g., aspirin, clopidogrel, etc.); 13.Subject has uncorrectable abnormal coagulation parameters(defined as platelet count = 75* 109/L or INR = 2.0); 14.Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to = 3* ULN or INR; 15.Subject is on dialysis. 16.Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial. 17.Participation in the active follow-up phase of another clinical study of an investigational drug or device. 18. Others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence MAE in 90 days after PCI; | — |
Secondary
| Measure | Time frame |
|---|---|
| The largest intraoperative reduction in CPO from baseline;Technical success;Creatinine clearance within 24 hours postoperation;Achieving rate of BP intraoperative in IABP;Achieving rate of cardiac output in Synflow3.0;The incidence of MACCE at 30 and 90 days;The incidence of MAE at 30 days;Changes of left ventricular ejection fraction (LVEF) from baseline at 30 and 90 days;Changes in NYHA from baseline at 30 and 90 days;Long stay;Performance;Incidence of severe hemolysis;Incidence of device-related serious vascular complications;Incidence of device-related serious vascular complications;AE/SAE;Device deficiencies; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed