Jie Zhao, MD, PhD

CONTACT

Lead Sponsor

China National Center for Cardiovascular Diseases

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

•Subjects must meet all of the following criteria to be enrolled:
•1. Age between 18 and 80 years old, both genders eligible;
•2. Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
•3. Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
•4. Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
•5. Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.

•Subjects will be excluded if they meet any of the following criteria:
•1. Total occlusion (TIMI 0 flow) lesion;
•2. In-stent restenosis lesion;
•3. Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
•4. Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
•5. Coronary artery bypass graft stenosis;
•6. Confirmed ST-elevation myocardial infarction;
•7. Cardiogenic shock or requiring mechanical respiratory and circulatory support;
•8. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
•9. Severe renal insufficiency or undergoing hemodialysis;
•10. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
•11. Systemic lupus erythematosus or other systemic autoimmune diseases;
•12. History of stroke within 6 months prior to enrollment;
•13. Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
•14. Currently participating in other drug or interventional medical device clinical studies;
•15. Other conditions deemed unsuitable for enrollment by the investigator.

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