A Randomized Study of Cutting Balloon Catheter for CAD

Inclusion criteria

• Subjects aged 18-80 years, including 18 and 80 years;
• Patients with stable or unstable angina, or old myocardial infarction or clinically judged silent myocardial ischemia (target vessel reference vessel diameter 2.00-4.00 mm (both inclusive)), luminal diameter stenosis ≥ 70%, or ≥ 50% by visual inspection with evidence of ischemia, TIMI blood flow ≥ grade 1, and requiring treatment with a cutting balloon dilatation catheter as considered by the operator;
• Able to understand the purpose of the study, participate the study willingly, sign the written informed consent form, and are available for and willing to follow-up as defined in this trial.

General exclusion criteria:

• Pregnant or lactating women or women who are planning pregnancy;
• Subjects with myocardial infarction occurred within one week; the myocardial enzyme TNI or TNT has not returned to normal although myocardial infarction has occurred for more than one week;
• Subjects who are considered by the investigator through angiography that the cutting balloon cannot pass through even dilatation with a small one and need a rotational atherectomy;
• Non-target vessels, which can be treated simultaneously with the target blood vessel, have not been treated well in advance, or the total number of lesions on the non-target blood vessel is > 3;
• NYHA Class IV patients;
• Patients with severe renal failure (creatinine > 443 μmol/L) or ongoing hemodialysis therapy;
• Heart transplant patients;
• Patients with graft vessel disease;
• Patients with hemodynamic instability or symptoms of shock;
• Patients with a life expectancy of no more than 1 year;
• Patients who are expected to undergo elective surgery within 1 month;
• Patients not eligible for coronary artery bypass grafting (CABG) procedure;
• Patients with a predisposition to bleeding, a history of active peptic ulcer, or contraindications to antiplatelet agents and anticoagulants, patients who cannot undergo anticoagulant therapy, or patients who have experienced hemorrhagic stroke within 6 months;
• Patients who are known to be allergic or contraindicated to heparin, contrast agents, etc.;
• Patients who are suffering from diseases that can cause difficulties in treatment and evaluation;
• Patients who have been selected and have participated in trials with other drug or medical device but have not reached the time limit of the primary study endpoint;
• Clinicians expect that the risk of interventional surgery is extremely high or other cases that should be ruled out;
• Patients who, in the judgment of the investigator, are poor compliance with the therapy and are unable to complete the trial as required;

Lesion related exclusion criteria:

• Left main lesion or lesion at a distance of ≤ 2 mm from the left main coronary artery;
• Patients with thrombosis suggested by angiography;
• Patients with a total occluded lesion and a TIMI flow grade 0;
• Coronary artery spasm (CAS) without organic stenosis;
• Left main lesion without protection from bypass grafts or collateral flow;
• In addition to the above contraindications, conditions diagnosed by the physician as unsuitable for the use of the device.