Evaluating the Safety and Effectiveness of a Vascular Interventional Robotic System in Assisting With Percutaneous Coronary Intervention Procedures: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Exclusion Criteria

• •1. Underwent other PCI within 72 hours before the PCI procedure.
• •2. Underwent PCI within 30 days before the PCI procedure and experienced a Major Adverse Cardiovascular Event (MACE).
• •3. Experienced acute Myocardial Infarction (MI) within one week before the PCI procedure.
• •4. Experienced cardiogenic shock within 48 hours before the PCI procedure.
• •5. Had a stroke within 30 days before the PCI procedure.
• •6. Subjects with active peptic ulcer or upper gastrointestinal bleeding within 6 months before the PCI procedure.
• •7. Severe heart failure (NYHA Class IV).
• •8. Pregnant and lactating women, or women planning to become pregnant during the clinical trial period.
• •9. Known allergy to aspirin, heparin, clopidogrel, contrast agents, metal materials, etc.
• •10. Patients with acute or chronic kidney disease (e.g., serum creatinine \>2.5 mg/dL or \>221 µmol/L) or on dialysis.
• •11. Subjects with a history of major bleeding or coagulation disorders within the past 6 months.
• •12. Subjects currently participating in another clinical study that has not completed the entire follow-up period.
• •13. The investigator determines that the patient has other conditions unsuitable for PCI assisted by the vascular interventional robotic system.
• •14. Requiring other treatment modalities (such as rotational atherectomy or laser therapy) in addition to balloon angioplasty and stent angioplasty.
• •15. Presence of more than two lesions in a single vessel requiring simultaneous treatment.
• •16. Presence of visible thrombus.
• •17. The target lesion is located in the left main coronary artery.
• •18. Severely tortuous lesions, severely calcified lesions, or other complex vascular conditions deemed by the investigator as unsuitable for PCI assisted by the vascular interventional robotic system.