A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.
试验速览
- 阶段
- 不适用
- 入组人数
- 2,456
- 试验地点
- 1
- 主要终点
- Composite Safety Endpoint
研究概览
简要总结
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
排除标准
- •Patients expected not to comply with 1 month DAPT
- •Patients requiring a planned staged PCI procedure more than one week after the index procedure
- •Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy
- •Active bleeding at the time of inclusion
- •Reference vessel diameter <2.25 - >4.0mm
- •Cardiogenic shock
- •Compliance with long-term single anti-platelet therapy unlikely
- •A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Participation in another clinical trial (12 months after index procedure).
研究组 & 干预措施
BioFreedom™ Drug Coated Stent (DCS)
BA9 drug coated stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 mm and 4.0 mm.
干预措施: Biofreedom™ Drug Coated Stent (DCS) (Device)
Gazelle™ Bare Metal Coronary Stent (BMS)
GAZELLE™ bare metal stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 and 4.0 mm.
干预措施: Gazelle™ Bare Metal Coronary Stent (BMS) (Device)
结局指标
主要结局
Composite Safety Endpoint
时间窗: one year
Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year
Primary Efficacy Endpoint
时间窗: one year
The incidence of clinically driven target lesion revascularization
次要结局
未报告次要终点