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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.
Stent underexpansion 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 underexpansion 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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Coronary Artery Disease
Columbia University Medical Center
Enrolling by invitation
Published on BioPortfolio: 2014-08-27T03:19:29-0400
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Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.
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