Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI

Inclusion criteria

• Be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months；
• Be able to understand the purpose of the study, voluntarily participate in and sign the informed consent, and be able and willing to accept the follow-up established in this study;
• Ischemic cardiomyopathy with single or multiple coronary artery lesions and diagnostic evidence [e.g., stable angina, unstable angina, or occult ischemia (evidence of myocardial ischemia)；
• Investigator is believed that the target atherosclerotic plaque needs to be incised and that predilation (if necessary) can enable the incised balloon to pass through the lesion；
• The presence of coronary artery stenosis confirmed by imaging examination, suitable for percutaneous coronary intervention, coronary vessel stenosis ≥70%; Or ≥50% (visual) with evidence of ischemia, TIMI ≥ level 1；
• The patient had autogenous coronary angiogenesis or restenosis, requiring stent treatment；
• The reference vessel diameter of target lesion was 2.0mm-4.0mm, and the lesion length was ≤20mm；
• When there are multiple lesions that need to be treated, only one in situ coronary lesion is selected as the target lesion, and the non-target lesion must be located on different vascular branches；

Exclusion criteria

• Patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy；
• Have had any myocardial infarction within a week；
• People who have an allergic reaction to contrast media or can't take medication
• There was severe renal failure with or without dialysis, glomerular filtration rate (eGFR) <30ml/min/1.73m2 or serum creatinine level >2.0 mg/ dl；
• cardiogenic shock；
• Patients who have received heart transplants；
• Patients who are not eligible for coronary artery bypass surgery；
• The patient had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery；
• The patient had a stroke or transient ischemic attack within 2 months before surgery；
• Patients in the pregnancy or lactation period；
• Participants are currently participating in any other clinical trial within 1 month prior to the trial；
• Patients deemed unsuitable for inclusion by other investigators；
• Severe calcified lesions and twisted lesions or lesion sites > 45 degrees angled；
• Lesions with significant endometrial tears
• Unprotected left main lesion；
• The contrast showed a blood clot；
• Scaffold fracture lesion；
• Distal stent lesion after stent implantation；