Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR

Korábbi kezelés

• Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or history of cerebral hemorrhage, subarachnoid hemorrhage, active peptic ulcer and gastrointestinal bleeding within 3 months before operation.
• Patients with acute myocardial infarction within 1 week before operation.
• Patients participating in clinical trials of other drugs or medical devices.
• ISR lesions intervened within 6 months before operation.
• The target vessel is severely calcified, tortuous and angulated, so it is expected that the drug balloon catheter will not pass successfully.

Más betegség

• Patients who are known to be allergic to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel or ticagrelor.
• According to the researcher's judgment, the patient's clinical condition is not suitable for this study, or the patient is expected to be unable to complete the follow-up study according to the protocol.
  • Disease related exclusion criteria
• Three vessel disease requiring treatment.

Laborértékek

• Left ventricular ejection fraction ≤ 30%.
• Acute or chronic renal insufficiency (serum creatinine > 2.0mg/dl or 178 μ mol / L).

Egyéb

• Subject related exclusion criteria
• A woman who is pregnant, lactating, or planning a pregnancy.
• Patients with Takayasu arteritis.
• Patients with life expectancy less than 1 year.
• The target lesion was total occlusion (Mehran type IV).
• The target and non target lesions were left main artery lesions.
• The target lesions were ostial, pontine and bifurcated lesions with branch diameter ≥ 2.5mm.
• More than 3 lesions (including target lesions and non target lesions) need to be treated in target vessels.
• Angiography confirmed thrombus in the target vessel.
• The lesions that could not be pre dilated successfully were grade C or above dissection after pre dilation, or residual stenosis > 30%, or TIMI blood flow < grade III.

• Subject related inclusion criteria
• Age≥18 years old \& ≤80 years old.
• Patients with stable angina pectoris, unstable angina pectoris, stable acute myocardial infarction or confirmed silent myocardial ischemia.
• Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
• It is suitable for patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
  • Desease related inclusion criteria
• The target lesions were in stent restenosis: Mehran type I, II and III stenosis.
• The stenosis rate of target lesion diameter was more than 70%, or more than 50%, accompanied by objective evidence of ischemia (such as stress electrocardiogram, myocardial perfusion imaging, FFR, etc.)
• The reference vessel diameter of the target lesion was 2.0-4.0 mm, and the target lesion length was less than or equal to 26 mm.
• It is expected that no more than two drug balloons will be used in each subject, and each target lesion can be covered by one drug balloon.
• At most 2 primary lesions need interventional treatment, and the distance from the target lesion is more than or equal to 10 mm, and can be successfully treated before the intervention of the target lesion.