The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions

Laborértékek

• General Exclusion Criteria
  • Patients with New York Heart Association (NYHA) Class IV heart failure.
  • Patients with contraindications to anti - platelet and anticoagulant therapy and are unable to receive anticoagulant treatment.
  • Patients who have had any myocardial infarction within one week.
  • Patients with an allergic reaction to contrast agents. ⑤ Patients with severe renal failure, with a serum creatinine level > 2.0 mg/dl (177 μmol/L).
  • Patients who have undergone heart transplantation.
  • Patients who have had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery.
  • ⑧ Patients who have had a stroke or transient ischemic attack within 3 months before surgery.
  • Pregnant or lactating patients. ⑩ Patients who are currently participating in any other clinical trials. ⑪ Patients whom the investigator deems unsuitable for enrollment. Exclusion Criteria Related to the Target Lesion (Detected by Coronary Angiography)
  • Tortuous lesions or lesions with an angulation of ≥ 45 degrees at the lesion site.
  • Lesions at the ostium with a distance of ≤ 2 mm from the left main coronary artery.
  • Unprotected left main coronary artery lesions. ④ Coronary angiography shows the presence of thrombus. ⑤ Before using the test device or the control device, the target lesion has a dissection of Type C or higher.
  • Target lesions that require treatment with coronary atherectomy or special balloons (such as scored balloons, spiked balloons, shock - wave lithotripsy systems, and cutting balloons of other brands).

• ① The age is between 18 and 80 years old (including the boundary values), and the subjects are male or non-pregnant female.
  • Have single or multiple coronary artery lesions and diagnosed ischemic heart disease (for example: stable angina pectoris, unstable angina pectoris, old myocardial infarction or asymptomatic myocardial ischemia).
  • There are coronary artery stenosis lesions confirmed by coronary angiography, which are suitable for percutaneous coronary intervention. The coronary artery stenosis is ≥ 70% (by visual estimation); or ≥ 50% (by visual estimation) and accompanied by evidence of ischemia, and the TIMI blood flow is ≥ Grade 1.
  • There are de novo or restenosis lesions in the coronary arteries of autologous or bypass graft vessels, and interventional treatment is required.
  • The visually estimated reference vessel diameter of the target lesion is 2.0mm - 4.0mm, and the lesion length is ≤ 20mm.
  • When there are multiple lesions that need to be treated, only one coronary artery lesion is selected as the target lesion, and the non-target lesions must be located on different vascular branches.
  • Be able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and be able to and willing to accept the follow-up as specified in this trial.