Status:
COMPLETED
Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography
Lead Sponsor:
Paieon Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
40+ years
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 wi...
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 un...
Eligibility Criteria
Inclusion
- Percutaneous coronary intervention indicated clinically.
- IVUS used as part of the standard procedure.
- Subject must be \>=40 yrs.
- Subject must provide written informed consent.
Exclusion
- Low image quality as determined by the investigator.
- Subject is pregnant or nursing.
- Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00973921
Start Date
September 1 2009
End Date
March 1 2010
Last Update
April 11 2014
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032