Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)

Exclusion Criteria

• •1. Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;
• •2. Cardiopulmonary resuscitation within 24 hours;
• •3. Patients who have had cardiogenic shock (systolic blood pressure \< 90 mmHg for more than 30 minutes or need catecholamines to maintain systolic blood pressure above 90 mmHg) or hemodynamic instability within 7 days before surgery;
• •4. Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;
• •5. Presence of aortic stenosis/calcification (aortic orifice area ≤ 0.6cm2), documented moderate to severe aortic regurgitation (echocardiographic assessment grade ≥2+); have an artificial aortic valve;
• •6. Severe pulmonary hypertension, right heart failure or severe tricuspid regurgitation;
• •7. Prior or current use of a persistent left ventricular assist device (LVAD), or use of IABP, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist device (such as Impella or Tandem Heart) within 7 days prior to surgery;
• •8. History of stroke or transient ischemic attack within 1 month before surgery;
• •9. Patients with renal failure (creatinine ≥3 times ULN) and may require dialysis treatment;
• •10. Subject has abnormal liver function (elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin levels ≥3 times ULN);
• •11. Moderate and severe anemia (hemoglobin \<90g/L); Subject has abnormalities in coagulation parameters that cannot be corrected (defined as platelet count ≤ 75×109/L or INR ≥2.0 or fibrinogen ≤1.50g/l); or inability to be treated with antiplatelet agents and anticoagulants;
• •12. Active visceral hemorrhage within 1 month;
• •13. History of allergy to heparin, contrast media, etc.;
• •14. Aortic abnormalities that preclude surgery, including aneurysms, extreme curvature, or calcification; or known severe arterial disease that precludes the trial, such as aortic dissection, Marfan syndrome, etc.;
• •15. Severe peripheral arterial obstructive disease (stent, tortuosity, stenosis, dissection, etc.) that prevents study device placement;
• •16. Infection at the site of the planned surgical puncture site or suspected active systemic infection with fever or need for antibiotic therapy;
• •17. Pregnant women and lactating women;
• •18. The subject has participated in other medical device clinical trials/drug clinical trials during the same period;
• •19. ECMO cannot be implanted or there are contraindications to its application and any other conditions that the investigator considers inappropriate to participate in this trial.