Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)

Prior treatment

• Inability to provide informed consent. Image Exclusion Criteria
  • 1\. Chronic total occlusion (CTO); 2. Left main lesion; 3. Bifurcation lesions treated with double stents; 4. Moderate to severe distortion, angulation or severe calcification lesions; 5. Coronary artery graft stenosis; 6. In-stent restenosis; 7. To be re-hospitalized for the other scheduled PCI treatment; 8. Myocardial bridge at the target lesion.

Other illness

• Stable angina or asymptomatic myocardial ischemia;
• Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
• A history of stroke within 6 months;
• History of severe renal insufficiency;
• Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;

Other

• Clinical Exclusion Criteria：
• Cardiogenic shock or requiring mechanical support for breathing and circulation;
• Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
• Life expectancy \< 12 months;
• Pregnant women;
• Patients not suitable for enrollment considered by researcher;
• Currently participating in another trial before reaching the primary endpoint;

• Age≥18 Years and \<80 years;
• ACS patients eligible for percutaneous coronary intervention;
• Successful preparation is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of type C-F dissection;
• Vessel diameter from 2.25mm-4.0 mm ;
• Lesion length ≤ 28 mm;
• A single culprit lesion or 1 lesion in each of two vessels ;
• Eligible for enrollment and provide written informed consent.