Glasgow Natural History Study Of Covered Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Procedural major adverse cardiac events (pMACE)
研究概览
简要总结
Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown. The GNOCCI study aims to evaluate long term outcomes after coronary perforation including patients treated with covered stents.
详细描述
Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown. Using an electronic data base, details of all coronary perforations are identified and anonymised patient and procedural details are recorded.Procedural major adverse cardiac events (pMACE) are defined as a composite of death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery within 24 hours of the index procedure. Two independent cardiologists adjudicate outcomes and differences in opinion are resolved by consensus with a third cardiologist.
The overall GNOCCI study aims are:
- Evaluate procedural and long term outcomes after coronary perforation
- Long term safety and clinical events in patients treated with covered stents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any coronary artery perforation during percutaneous coronary intervention
排除标准
- 未提供
结局指标
主要结局
Procedural major adverse cardiac events (pMACE)
时间窗: 24 hours of the index procedure.
Defined as a composite of death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery
次要结局
- Stent thrombosis(Up to 10 years)
- MACE(Up to 10 years)
- Unsuccessful covered stent deployment(24 hours of the index procedure.)
研究者
Dr Thomas J Ford
Clinical Research Fellow | Honorary Fellow (Interventional Cardiology)
NHS National Waiting Times Centre Board