Novara Platinum CROMium Everolimus EluTing StEnt SpontaneoUs RegiStry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- QCA : nominal stent lenght ratio
研究概览
简要总结
Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . This analysis aims to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population using quantitative angiographic analysis (QCA).
详细描述
Aims: Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms .
The aim of this analysis is to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population .
Methods: Quantitative angiographic analysis (QCA) of PtCr stents deployed in consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 will be performed by an independent core laboratory. In particular QCA : nominal stent lenght ratio will be calculated for every PtCr stent.
Clinical follow up with data about overall and cardiac mortality, myocardial infarction and target vessel revascularization will also be performed.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PCI with at least 1 platinum-chromium platform-based stent
- •presence of at least 2 ortogonal angiographic projections of the deployed stent to allow proper quantitative coronary angiography
排除标准
- •age <18 >90
结局指标
主要结局
QCA : nominal stent lenght ratio
时间窗: 1 day
QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation
次要结局
- cardiovascular mortality(1 year)
- myocardial infarction(1 year)
- target vessel failure(1 year)
- Macroscopical stent deformation(1 day)
研究者
Lupi Alessandro
M.D.
Azienda Ospedaliero Universitaria Maggiore della Carita