Angina, Myocardial Infarction
Conditions
Keywords
coronary stents
Brief summary
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.
Detailed description
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.
Interventions
Preintervention imaging
Conventional coronary intervention
Sponsors
Study design
Eligibility
Inclusion criteria
Clinical indication for coronary angiography and intervention due to stentfailure, both stentrestenosis and stentthrombosis in stable patients or unstable patients with acute coronary syndrome.
Exclusion criteria
* Patient not able to give informed consent. * Unwillingness. * Life expectancy \< 5 years. * Reduced kidney function with GRF\<45. * Coronary artery diameter \< 2.5mm. * Pregnancy. * Patients without 11-digit Norwegian personal number.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion revascularisation | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| non-fatal myocardial infarction | 5 years |
| Cardiovascular mortality | 5 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in kidney function | 5 years | Number of participants with more than 25% increase in serum creatinin. |
Countries
Norway