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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973921
• Other study ID #: Paieon-Columbia-SO
• Status: Completed
• Phase: N/A
• First received: September 6, 2009
• Last updated: March 6, 2014
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2014
• Source: Paieon Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Paieon Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.	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	No
Primary	The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.	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	No
Secondary	Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .	The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.	On day of procedure	No
Secondary	Correlation of Stent Diameter Measurements Between the QCA and IVUS .	The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS	On day of procedure	No