Clinical Impact of Drug-Coated-Balloon-based Versus Drug-Eluting-Stent-based Intervention in Patients With Multivessel Coronary Artery Disease : A Prospective, Multicenter, Active-controlled, Randomized, Single-blind, Investigator-initiated Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 892
- 主要终点
- Net Clinical outcome (NCO)
研究概览
简要总结
This study aimes to compare the clinical outcomes of drug-coated balloon-based percutaneous coronary intervention (DCB-based PCI) and drug-eluting stent-based percutaneous coronary intervention (DES-based PCI) in patients with multivessel coronary artery lesions measuring 2.25 mm to 4.0 mm in diameter through a prospective, multicenter, active-controlled, randomized, investigator-initiated clinical trial.
详细描述
This study is a prospective, multicenter, active-controlled, randomized, single-blind, investigator-initiated clinical trial in patients with multivessel coronary artery disease.
The clinical outcomes of the DCB-based PCI group and the DES-based PCI group, assigned through 1:1 random assignment, will be compared, and approximately 9 hospitals will participate.
The primary endpoint is the Net Clinical Outcome (NCE) at 12 months after the procedure, and secondary endpoints will be followed up to 36 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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults aged 20 years or older with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI).
- •In cases of ST-segment elevation myocardial infarction (STEMI), patients who have undergone successful primary percutaneous coronary intervention (PCI) without complications, at least 48 hours post-procedure, and whose target lesion(s) show no evidence of thrombus.
- •Patients with multivessel coronary artery disease, defined as angiographic stenosis of 50% in at least two major epicardial coronary arteries requiring PCI as determined by the investigator.
- •Reference vessel diameter (RVD) of the target lesion(s) between 2.25 mm and 4.0 mm by visual estimation or quantitative coronary angiography (QCA).
- •Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB).
- •Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements.
排除标准
- •Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support.
- •Patients with a life expectancy of less than 2 years due to comorbid conditions.
- •Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies.
- •Women who are pregnant or have childbearing potential.
- •Patients with a known hypersensitivity or allergy to contrast media, L-605 Cobalt-Chromium (Co-Cr) alloy, PLA and PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus.
- •Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft.
- •Patients with target vessels/lesions that are excessively tortuous, angulated, or severely calcified, such that pre-dilatation cannot be performed or has failed, making the application of the investigational medical device difficult.
研究组 & 干预措施
GENOSS® DCB
Paclitaxel-coated PTCA Balloon Catheter
干预措施: GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter) (Device)
Second, Third Generation Drug-Eluting Coronary Stent System
All-comer current-generation biodegradable or durable polymer-based drug-eluting stents (DES)
干预措施: Second, Third Generation Drug-Eluting Coronary Stent System (Device)
结局指标
主要结局
Net Clinical outcome (NCO)
时间窗: at 12 months after procedure
The primary endpoint is the net clinical outcome, defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization (TVR), and BARC (Bleeding Academic Research Consortium) type 2 to 5 bleeding.
次要结局
- All-cause death(at 24, and 36 months after procedure)
- Ischemic or hemorrhagic stroke(at 24, and 36 months after procedure)
- Net Clinical outcome (NCO)(at 24, and 36 months after procedure)
- Major adverse cardiovascular events (MACEs)(at 24, and 36 months after procedure)
- Major adverse cardiac events (MACE)(at 24, and 36 months after procedure)
- Major bleeding(at 24, and 36 months after procedure)
- Cardiac death(at 24, and 36 months after procedure)
- Myocardial infarction(at 24, and 36 months after procedure)
- Target vessel-myocardial infaction (TV-MI)(at 24, and 36 months after procedure)
- Target lesion revascularization (TLR)(at 24, and 36 months after procedure)
- Target vessel revascularization (TVR)(at 24, and 36 months after procedure)
- Definite or probable stent thrombosis(at 24, and 36 months after procedure)