Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions

Más betegség

• Patients with ST-segment elevation myocardial infarction (STEMI)
• Patients with a history of cardiogenic shock
• Patients who have or currently have medical conditions such as psychiatric disorders that significantly affect this clinical trial

Laborértékek

• Patients with platelet aggregation or disorders at risk of increased bleeding, such as gastrointestinal ulcers, which limit platelet aggregation inhibitory therapy and anticoagulant therapy
• Patients with a left ventricular ejection fraction of less than 30% on echocardiography
• Patients with renal insufficiency (eGFR<30mL/min)

Egyéb

• Patients who are contraindicated in aspirin, heparin, ticagrelor, iopromide, clopidogrel, prasugrel and paclitaxel
• Pregnant or lactating women
• The patients have a life expectancy of less than 12 months
• Patients who, in the investigator's judgment, may not be suitable for this clinical trial or may increase the risk associated with participation in the study
• Patients who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date
• Patients who are unsuitable for the study according to the investigator judges
• Patients with left main coronary lesion
• Patients with graft vessel lesion
• Patients who cannot apply pre-dilation or fail in pre-dilation to apply medical devices for clinical trials
• Patients with one of the following items after pre-dilation of the target lesion
  • When FFR (Functional measurement) is measured as ≤ 0.8 in large vessels with a reference vessel diameter exceeding 2.75mm (However, depending on the judgment of the investigator, FFR measurement may not be performed.)
  • Patients who need stenting due to vascular dissection that restricts blood flow
  • Residual stenosis > 30%
  • TIMI flow < 3

• Age ≥19 years old
• Patients requiring PCI with coronary de novo lesions
• Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
• Women of childbearing age who agreed to use one or more of the clinically appropriate methods of contraception during the trial period.
• In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form
• Patients with significant coronary artery stenosis (> 50% diameter stenosis on coronary angiography)
• On coronary angiography, the length of the lesion is less than 34 mm and the diameter of the reference vessel of the coronary artery is 2.0 - 4.0mm.