NCT05643430进行中（未招募）不适用
A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 17
- 主要终点
- TLF
研究概览
简要总结
The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- •Pregnant and breastfeeding women
- •Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- •Patients not expected to comply with 1 month of DAPT
- •Staged procedures in the target vessel
- •Active bleeding at the time of inclusion
- •Cardiogenic shock
- •Unlikely compliance with long-term single anti-platelet therapy
- •Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
- •Currently participating in another trial before reaching primary endpoint
- •Patients under judicial protection, tutorship or curatorship (France only)
结局指标
主要结局
TLF
时间窗: at 9 months after index procedure
Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI
次要结局
- CD-TLR(Clinical endpoints measured at 9 and 24 months)
- Bleeding rate (BARC 2-5)(Clinical endpoints measured at 9 and 24 months)
- Cardiovascular Death(Clinical endpoints measured at 9 and 24 months)
- TVR(Clinical endpoints measured at 9 and 24 months)
- Stent thrombosis rate - definite/probable(Clinical endpoints measured at 9 and 24 months)
- Peri-procedural endpoints(Peri-procedural endpoints measured at 9 and 24 months)
- TV-MI(Clinical endpoints measured at 9 and 24 months)
- All cause mortality(Clinical endpoints measured at 9 and 24 months)
研究者
研究点 (17)
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