Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00973921

Run by

Paieon Inc.

People needed

40

Starts

2009-09-01

Expected to finish

2010-03-01

Last updated by the study team

2014-04-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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