NCT07582250尚未招募不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,548
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years and ≤ 80 years;
- •Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence;
- •Patients without contraindications to coronary revascularization (PCI or CABG);
- •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:
- •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).
- •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%.
- •Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).
- •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.
排除标准
- 未提供
研究者
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