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

Inclusion criteria

1.18 years ≤ Age ≤ 80 years; 2.Presence of clinical indications for PCI and requiring PCI treatment; 3.The subject or their legal guardian is able to understand the trial objectives, voluntarily signs the informed consent form, and is willing to comply with follow-up procedures.

4.Visual estimation of target lesion diameter stenosis ≥70% (or ≥50% with clinical evidence of myocardial ischemia); 5.2.25 mm ≤ Visual reference vessel diameter ≤ 4.0 mm; 6.The target lesion can be fully covered by a single stent, with at least 2.0 mm of normal vessel segment at the proximal and distal edges of the lesion; 7.Number of target vessels requiring treatment ≤ 2; one target lesion treated with one stent; staged treatment of the target lesion is not allowed.

Exclusion criteria

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