Optical Coherence Tomography (OCT) Guided Compared to Conventional Angiography Guided Coronary Intervention in Stentfailure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Target lesion revascularisation
研究概览
简要总结
Coronary artery intervention with stents is a routine procedure with several clinical indications. A stentfailure, ie stentrestenosis and/or stentthrombosis will occur in some patients. Several different mechanisms have been suggested. Stentfailure may be caused by mechanical properties of the stent. This may be secondary to suboptimal stentimplantation, ie over/undersizing or acquired ie malapposition or stentfracture. These stentproperties may be difficult to identify with conventional coronary angiography due to low image resolution. The hypothesis of the study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment with a subsequent reduction in later stentfailure.
详细描述
The hypothesis of the PROCTOR study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment in stent failure. However, the prevalence of stentfailure (ie stent malapposition, stentfracture, stentedgedissections etc) not causing clinical endpoints is not known. In a subset of patients (n=100) with previously implanted stents performing a new coronary angiography based on clinical indication, functional or patent stents (decided by Heart team) will be characterized with OCT and the patients followed for 5 years. The purpose of this substudy, OCT IPS (OCT In Patent Stents), is to estimate the prevalence of stentpathology in patent or functional stents and compare findings with the active arm of PROCTOR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Clinical indication for coronary angiography and intervention due to stentfailure, both stentrestenosis and stentthrombosis in stable patients or unstable patients with acute coronary syndrome.
排除标准
- •Patient not able to give informed consent.
- •Unwillingness.
- •Life expectancy < 5 years.
- •Reduced kidney function with GRF<
- •Coronary artery diameter < 2.5mm.
- •Pregnancy.
- •Patients without 11-digit Norwegian personal number.
研究组 & 干预措施
OCT guided coronary intervention
Coronary angiography and optical coherence tomography imaging
干预措施: Coronary angiography (Radiation)
OCT guided coronary intervention
Coronary angiography and optical coherence tomography imaging
干预措施: Optical coherence tomography (Other)
Conventional coronary intervention
Coronary angiography
干预措施: Coronary angiography (Radiation)
结局指标
主要结局
Target lesion revascularisation
时间窗: 5 years
次要结局
- non-fatal myocardial infarction(5 years)
- Cardiovascular mortality(5 years)
研究者
Eigil Fossum
MD, PhD
Oslo University Hospital