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

Inclusion criteria

• 18 Years to 90 Years
• The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI
• The subject is diagnosed with acute or chronic coronary syndrome, and

• LVEF≤ 35% or
• LVEF ≤ 40% and NYHA Classification is III or IV
• Informed consent
• The participant meets all the above clinical inclusion criteria and must comply with at least one of the following imaging criteria.

• At least two coronary artery CTOs (diameter of occluded artery ≥ 2.5mm) 2. Unprotected left main coronary artery disease, and meeting one or more complex operating standards 3. Three-vessel disease and meeting two or more complex operating standards

Complex operations are defined as:

• Bifurcation lesions require treatment of dual branches (including stents and PTCA)
• Calcification lesions require complex operation or instrument assistance (Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy)
• Severe distortion requires complex operations
• The target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 )

Exclusion criteria

• Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;
• Cardiopulmonary resuscitation within 24 hours;
• 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;
• Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;
• 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;
• Severe pulmonary hypertension, right heart failure or severe tricuspid regurgitation;
• 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;
• History of stroke or transient ischemic attack within 1 month before surgery;
• Patients with renal failure (creatinine ≥3 times ULN) and may require dialysis treatment;
• Subject has abnormal liver function (elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin levels ≥3 times ULN);
• 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;
• Active visceral hemorrhage within 1 month;
• History of allergy to heparin, contrast media, etc.;
• 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.;
• Severe peripheral arterial obstructive disease (stent, tortuosity, stenosis, dissection, etc.) that prevents study device placement;
• Infection at the site of the planned surgical puncture site or suspected active systemic infection with fever or need for antibiotic therapy;
• Pregnant women and lactating women;
• The subject has participated in other medical device clinical trials/drug clinical trials during the same period;
• 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.