A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions

A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions

To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.

General Inclusion Criteria:

1. Patients aged ≥ 18 years and ≤ 80 years;
2. Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence;
3. Patients without contraindications to coronary revascularization (PCI or CABG);
4. Patients who can understand the study purpose, voluntarily participate in the trial, sign the informed consent form, and are willing to complete follow-up as required by the protocol.

Angiographic Inclusion Criteria:

1. The target lesions are de novo native coronary artery lesions, located in 1 or 2 different coronary arteries; the number of target lesions in each coronary artery shall not exceed 1 (for two-vessel disease, a maximum of 2 target lesions are permitted).

2. All target lesions shall meet the following requirements:

   ① The reference vessel diameter is between 2.25 mm and 4.0 mm, and the lesion length ≤ 30 mm;

   ② The visual estimated stenosis degree before procedure ≥ 70%, or ≥ 50% with documented ischemic evidence;

   ③ Successful pre-dilation: defined as no NHLBI type C or higher dissection; TIMI flow grade 3; residual stenosis ≤ 30%.

3. Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).

4. If the patient has non-target lesions requiring concurrent intervention, such non-target lesions shall be successfully treated prior to the treatment of target lesions.