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

Inclusion criteria

• - Radiography inclusion criteria

• angiographically confirmed de novo coronary artery lesion;
• target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
• target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);
• either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;
• successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria

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• subjects at the age between ≥18 and ≤80 years old;
• patients with symptoms or evidence of myocardial ischaemia;
• subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.

Exclusion criteria

• 1. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels > 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria

• Any patient with myocardial infarction within one month;
• 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%;
• Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
• 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;
• Patients with severe renal failure(eGFR<30ml/minute) or such medical history, failure to comply with angiography conditions;
• Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;
• Patients who plans to accept selective operation within 1 year;
• Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
• Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.