Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions
This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.
- EligibilityCriteria: Inclusion Criteria:  1. Voluntary participation in this trial and signed the informed consent form; 2. Age: ≥18 and ≤80 years old, regardless of gender; 3. The existence of coronary artery stenosis lesions accompanied by evidence of ischemia in the heart (such as symptomatic coronary heart disease, stable/unstable angina pectoris or asymptomatic myocardial ischemia), suitable for percutaneous interventional therapy.  Exclusion Criteria:  1. Acute myocardial infarction (AMI) within 7 days before surgery; 2. Serum creatinine level >2.0 mg/dL (177 umol/L) within 7 days before surgery; 3. Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery; 4. Stroke or transient ischemic attack (TIA) within 3 months before surgery; 5. Known left ventricular ejection fraction (LVEF) <30% (if LVEF is unknown, it can be measured during this surgery); 6. Known allergies to aspirin or heparin or the existence of contraindications that prevent the subjects from receiving sufficient preoperative medications; 7. Known subjects allergic to ingredients in the test product or contrast agent; 8. Known subjects who are pregnant or breastfeeding; 9. Planned to use coronary atherectomy, laser ablation, other scoring / spiked / cutting balloons (non-study devices) or shock wave balloons to treat the target lesion at the same time; 10. Subjects participating in other drug or device clinical studies; 11. Other situations that are not suitable for participation in this study as assessed by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult