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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paieon Inc.
ClinicalTrials.gov Identifier:
NCT00973921
First received: September 6, 2009
Last updated: March 6, 2014
Last verified: March 2014
Results First Received: June 5, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Retrospective
Condition: Coronary Artery Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Coronary Stenting Evaluation With IVUS The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.

Participant Flow:   Overall Study
    Coronary Stenting Evaluation With IVUS  
STARTED     40  
COMPLETED     31  
NOT COMPLETED     9  
IVUS results were not available                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Coronary Stenting Evaluation With IVUS The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.

Baseline Measures
    Coronary Stenting Evaluation With IVUS  
Number of Participants  
[units: participants]
  40  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     28  
Age  
[units: years]
Mean ± Standard Deviation
  62.2  ± 9.2  
Gender  
[units: participants]
 
Female     10  
Male     30  
Region of Enrollment  
[units: participants]
 
United States     40  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.   [ Time Frame: On procedure day ]

3.  Secondary:   Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .   [ Time Frame: On day of procedure ]

4.  Secondary:   Correlation of Stent Diameter Measurements Between the QCA and IVUS .   [ Time Frame: On day of procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a relatively small study designed to evaluate the procedural decision about post-deployment dilatation not powered to evaluate the outcome of patients. The operator decision of his post-dilatation strategy was qualitative.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Giora Weisz MD
Organization: Columbia University Medical Center
phone: 212-305 7060
e-mail: gw2128@mail.cumc.columbia.edu


No publications provided


Responsible Party: Paieon Inc.
ClinicalTrials.gov Identifier: NCT00973921     History of Changes
Other Study ID Numbers: Paieon-Columbia-SO
Study First Received: September 6, 2009
Results First Received: June 5, 2012
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board