Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography
|ClinicalTrials.gov Identifier: NCT00973921|
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : April 11, 2014
Last Update Posted : April 11, 2014
|Condition or disease|
|Coronary Artery Disease|
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
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Stent deployment evaluation
The study group consisted of patients that underwent IVUS guided stent implantation. Stent deployment evaluation was done with the experimental StentOptimizer as well as IVUS and QCA.
- The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard. [ Time Frame: On the procedure day ]IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.
- The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard. [ Time Frame: On procedure day ]IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.
- Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS . [ Time Frame: On day of procedure ]The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.
- Correlation of Stent Diameter Measurements Between the QCA and IVUS . [ Time Frame: On day of procedure ]The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973921
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Giora Weisz, MD||Columbia University|