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

March 6, 2014 updated by: Paieon Inc.

Comparison of StentOptimizer - an Angiography-based Post Deployment Stent Analysis Application With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography for Post Deployment Stent Analysis

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients that underwent IVUS guided stent implantation in the institution.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On the procedure day
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.
On procedure day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On day of procedure
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
On day of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paieon Inc.

Investigators

  • Principal Investigator: Giora Weisz, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 6, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Paieon-Columbia-SO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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