跳至主要内容
临床试验/NCT02817802
NCT02817802进行中(未招募)不适用

BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV

Biotronik AG2 个研究点 分布在 2 个国家目标入组 2,066 人开始时间: 2016年8月最近更新:
适应症

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

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

研究者

发起方
Biotronik AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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