Interventional Left Ventricular Assist System for PCI in CHIP Patients

Exclusion Criteria

• •1. Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP \<90 mmHg for ≥30 min or requiring supportive measures to maintain SBP \>90 mmHg and end-organ hypoperfusion (urine output \<30 ml/h or cool extremities).
• •2. STEMI or CK-MB did not return to the normal range within 24 hours.
• •3. Cardiac arrest with cardiopulmonary resuscitation within 24 hours.
• •4. Left ventricular mural thrombus.
• •5. After aortic valve replacement surgery (mechanical, bioprosthetic).
• •6. Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.
• •7. Moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency.
• •8. Atrial septal or ventricular septal defects (including post-infarction VSD), or post-myocardial infarction Free-Wall Rupture, or papillary muscle rupture.
• •9. Severe right heart failure or severe tricuspid valve insufficiency.
• •10. Disease or abnormality of the aorta that interferes with the procedure, including Marfan syndrome, coarctation of aortic, aortic aneurysm, severe tortuosity or calcification of the aorta.
• •11. Severe peripheral arterial stenosis or occlusive lesions.
• •12. Uncorrectable moderate or severe anemia prior to the procedure (hemoglobin \<90 g/L). Abnormal coagulation function (routine blood test indicates platelet count less than 75×109/L, INR ≥2.0, or fibrinogen ≤1.5 g/L).
• •13. Known contraindications to heparin, contrast agents, or study-required medications (e.g., aspirin, clopidogrel); history of Heparin-induced thrombocytopenia.
• •14. Active hemorrhage within 1 month.
• •15. History of stroke or TIA or permanent neurologic deficits within one month prior to the procedure.
• •16. Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L) within 7 days.
• •17. Liver dysfunction: liver AST, ALT and bilirubin \>3 times the upper limit of normal within 7 days.
• •18. Presence or suspected presence of infective endocarditis or systemic infection.
• •19. Women who are pregnant, breastfeeding, or planning pregnancy during the trial.
• •20. Participation in another drug or medical device clinical trial.
• •21. Other conditions deemed by the investigator as unsuitable for participation in this trial.
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