Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®

Exclusion Criteria

• •1. Subjects with myocardial infarction within one week, or subjects whose troponin has not returned to normal despite the onset of myocardial infarction for more than one week;
• •2. Subjects with severe congestive heart failure or NYHA IV heart failure;
• •3. Women who are pregnant or breastfeeding;
• •4. Subjects whose life expectancy does not exceed 1 year or who have factors that make clinical follow-up difficult;
• •5. Subjects with stroke within 6 months;
• •6. Subjects who are participating in any other clinical trials and have not reached the primary clinical endpoint;
• •9. Heart transplant;
• •10. Cardiogenic shock;
• •11. Coronary artery spasm without significant stenosis;
• •12. The researchers think that the subjects are not suitable for others inclusion reason;
• •13. Evidence of extensive thrombus in the target vessel before intervention;
• •14. Coronary artery bypass grafting using vein grafts;
• •15. Complete occlusion of the target vessel (TIMI grade 0 blood flow before operation)
• •16. Target vessels are distorted or have calcified lesions that cannot be pre-dilated successfully;
• •17. Lesions within 5 mm from the coronary artery ostia;
• •18. Lesions that cannot be treated with PTCA or other interventional techniques;
• •19. After pre-dilation of the target lesion, residual stenosis \> 50% or TIMI blood flow \< grade 3, and/or type C or above dissection;
• •20. Subjects with bleeding constitution, contraindicated anticoagulant or antiplatelet drugs;
• •21. Subjects who cannot tolerate aspirin and/or clopidogrel or have a history of neutropenia or thrombocytopenia, or severe liver insufficiency that prohibits clopidogrel;
• •22. Subjects who are known to be intolerant or allergic to heparin, contrast medium, paclitaxel, iopromide, polylactic acid-glycolic acid polymer, stainless steel, etc.;
• •23. Leukopenia (white blood cell count \<3×109/L for more than 3 days) or neutropenia (ANC\<1000 neutrophils/mm3 for more than 3 days) or history of thrombocytopenia (\<100,000 platelets/mm3) subjects;
• •24. Subjects with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months;