BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- Biotronik AG
- 入组人数
- 2,066
- 试验地点
- 2
- 主要终点
- Target Lesion Failure (TLF)* at 12 months
研究概览
简要总结
The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting
详细描述
Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy.Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.
The aim of this observational registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 未提供
结局指标
主要结局
Target Lesion Failure (TLF)* at 12 months
时间窗: 12 month
次要结局
未报告次要终点
