Coronary Artery Disease Clinical Trial
Official title:
Comparison of StentOptimizer - an Angiography-based Post Deployment Stent Analysis Application With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography for Post Deployment Stent Analysis
The primary objective of this study is to determine the diagnostic efficiency and accuracy of using the StentOptimizer. The ability of StentOptimizer to influence post deployment treatment strategy will be assessed and compared to the IVUS system. In addition, the correlation of diameter measurements between the StentOptimizer, IVUS and 2D QCA will be assessed. The StentOptimizer software, IVUS and 2D QCA were all part of the clinical procedure outside the study. The analysis of post deployment treatment decisions and diameter measurements using those modalities retrospectively make this an observational study.
Stent under-expansion is defined as the minimum stent area by itself or compared with a
predefined reference. It plays a role in the pathogenesis of adverse events following stent
deployment. Stent under-expansion has been a consistent finding in IVUS reports of acute or
subacute BMS or DES thrombosis.
Post intervention imaging can determine whether there is adequate stent expansion. Currently
the only available tool for evaluation of properness of stent deployment is intravascular
ultrasound (IVUS). IVUS procedure is invasive, labor intensified, associated with radiation
and contrast media use, and is not free of complications. In many medical centers, IVUS is
not used routinely because of lack of knowledge and expertise in reading it, and it's
relatively high price.
The StentOptimizer is an angiography based software tool aimed to enhance visualization of
deployed stents and to provide the physician with quantitative data regarding stent
dimensions. The StentOptimizer is part of an image acquisition and processing software
system (IC-Pro), designed as an add-on to conventional X-ray angiography systems.
An enhanced stent image is produced using the radiopaque markers of the delivery balloon
from several frames (minimum 20). The result is a still image of the stent with enhanced
edges and the region of interest around it
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Observational Model: Case-Only, Time Perspective: Retrospective
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