Clinical trial NCT00973921: Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Stent
under-expansion
StentOp
StentOptimizer
IVUS
IC-PRO
image enhancement
Lead sponsor: Paieon Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients that underwent IVUS guided stent implantation in the institution.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Percutaneous coronary intervention indicated clinically.
2. IVUS used as part of the standard procedure.
3. Subject must be \>=40 yrs.
4. Subject must provide written informed consent.

Exclusion Criteria:

1. Low image quality as determined by the investigator.
2. Subject is pregnant or nursing.
3. Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.

Primary outcomes:
measure: The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.
timeFrame: On the procedure day
measure: The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.
timeFrame: On procedure day
Secondary outcomes:
measure: Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .
timeFrame: On day of procedure
measure: Correlation of Stent Diameter Measurements Between the QCA and IVUS .
timeFrame: On day of procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Giora Weisz, MD
role: PRINCIPAL_INVESTIGATOR
References: