Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial
Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.
Inclusion Criteria:
18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） .
Reference vessel diameter ≥3.0 mm, and <4.5mm. Lesion length of ≤20 mm Written informed consent
Exclusion Criteria:
Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus