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Completed

NCT Number: NCT00973921

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Paieon Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2009
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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