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

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ClinicalTrials.gov Identifier: NCT00973921
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : April 11, 2014
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
Paieon Inc.

Study Description
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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.

Condition or disease
Coronary Artery Disease

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

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients that underwent IVUS guided stent implantation in the institution.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Paieon Inc.
Investigators
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Principal Investigator: Giora Weisz, MD Columbia University
More Information
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Responsible Party: Paieon Inc.
ClinicalTrials.gov Identifier: NCT00973921    
Other Study ID Numbers: Paieon-Columbia-SO
First Posted: September 9, 2009    Key Record Dates
Results First Posted: April 11, 2014
Last Update Posted: April 11, 2014
Last Verified: March 2014
Keywords provided by Paieon Inc.:
Stent
under-expansion
StentOp
StentOptimizer
 IVUS
IC-PRO
image enhancement
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases