A Prospective, Multicentric, Randomized Controlled Clinical Trial of Drug-coated Balloons in the Treatment of Big de Novo Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- late lumen loss，LLL
研究概览
简要总结
A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old;
- •Asymptomatic myocardial ischemia, stable or unstable angina;
- •The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation;
- •Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months;
- •The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm.
排除标准
- •Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months;
- •Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol;
- •Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants;
- •Life expectancy is less than 12 months;
- •eGFR≤30ml/min/1.73m2 or blood purification treatment;
- •LVEF≤40% or NYHA cardiac function class≥III;
- •Clinical conditions of severe hepatic insufficiency and coagulation disorder
- •Pregnant or breastfeeding women;
- •Participating in another clinical trial and have not completed the primary endpoint observation of the trial;
- •Reference lumen diameter > 4.0mm;
- •Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion;
- •The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy;
- •Chronic total occlusive disease;
- •Left main stem disease;
- •Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions;
- •Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing
结局指标
主要结局
late lumen loss，LLL
时间窗: 12 months after PCI
late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI
次要结局
- target lesion failure，TLF(12 months after PCI)
研究者
Xue Yu
Vice director of cardiology department
Beijing Hospital