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Prospective Randomized Optical Coherence Tomography Oslo tRial — PROCTOR  

Myocardial Infarction Clinical Trial

Official title:
Optical Coherence Tomography (OCT) Guided Compared to Conventional Angiography Guided Coronary Intervention in Stentfailure

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02337348
Study type Interventional
Source Oslo University Hospital
Contact
Status Terminated
Phase N/A
Start date August 2014
Completion date January 31, 2019
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