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临床试验/NCT02398955
NCT02398955Unknown不适用

Biomime Biosorbable Polymer Sirolimus-ELuting Stent in alL-comers patIeNts Treated With Percutaneous Coronary Interventions: the BELLINI Registry

Azienda Ospedaliero Universitaria Maggiore della Carita1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
250
试验地点
1
主要终点
target vessel revascularization

研究概览

简要总结

Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent

排除标准

  • patients <18 years old

结局指标

主要结局

target vessel revascularization

时间窗: 1 year

rate of target vessel percutaneous or surgical reintervention for recurrent symptoms or inducible ischemia at follow up testes

次要结局

  • cardiac death(1 year)
  • reinfarction(1 year)
  • death from any cause(1 year)
  • target lesion revascularization(1 year)

研究者

发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lupi Alessandro

Dr Alessandro Lupi

Azienda Ospedaliero Universitaria Maggiore della Carita

研究点 (1)

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