Coronary heart disease
Conditions
Interventions
Control group: intra-aortic balloon pump (IABP)
Sponsors
General Hospital of Northern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old= patient age =90 years old AND patient is not in pregnancy or lactation; 2. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery; 3. Left Ventricular Ejection Fraction (LVEF) = 35% AND at least one of the following criteria: • Intervention on the last patent coronary conduit, or • Intervention on an unprotected left main coronary artery Or b) LVEF = 30% and intervention in patient presenting with triple vessel disease. 4. Patient who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Exclusion criteria
Exclusion criteria: 1. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR; 2. Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment; 3. Patient is in cardiogenic shock; 4. Mural thrombus in the left ventricle; 5. Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects; 6. The presence of mechanical aortic or mitral valve or heart constrictive device; 7. The presence of aortic stenosis (aortic orifice area =1.5cm²); 8. The presence of moderate to severe aortic or mitral or tricuspid insufficiency; 9. The presence of severe peripheral vascular disease that would preclude the placement of the percutaneous mechanical circulatory assist device; 10. Severe aortic diseases such as aortic dissection and aortic aneurysm; 11. Active infective endocarditis or other active infections; 12. Chronic renal insufficiency (creatinine clearance=30ml/min); 13. Liver dysfunction (elevation of liver enzymes and bilirubin levels to =3xULN or INR=2); 14. The presence of uncorrectable abnormal coagulation (platelet count=75,000/mm^3 or INR=2.0 or fibrinogen=1.50 g/l); 15. The presence of uncorrected moderate to severe anemia (hemoglobin <90 g/L); 16. History of stroke or TIA within 1 month of enrollment; 17. Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.); 18. Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research; 19. Patient with poor compliance and could not complete the study as required determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of death;Incidence of myocardial infarction;Incidence of stroke;Incidence of target vessel revascularization;Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia ;Incidence of acute kidney injury;Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion;Incidence of increasing in aortic insufficiency by more than one grade ;Incidence of severe hypotension;Incidence of failure to achieve angiographic success ;Incidence of serious vascular and access-related complications;Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days;Hemodynamic support success rate during PCI procedure;Technical success rate ;Procedural success rate ;Change in LVEF compared to baseline;Improvement in cardiac function;Evaluation of Experimental device performance ; | — |
Countries
China
Contacts
Public ContactHan Yaling
General Hospital of Northern Theater Command
Outcome results
None listed