The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT

Inclusion Criteria

• •1. angiographically confirmed de novo coronary artery lesion;
• •2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
• •3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);
• •4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;
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• •1. subjects at the age between ≥18 and ≤80 years old;
• •2. patients with symptoms or evidence of myocardial ischaemia;
• •3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.
• •1. Any patient with myocardial infarction within one month;
• •2. Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;
• •3. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
• •4. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
• •5. Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions;
• •6. Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;
• •7. Patients who plans to accept selective operation within 1 year;
• •8. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
• •9. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.