CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00973921
NCT00973921N/ACompleted

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

Paieon Inc.·observational·Posted Sep 9, 2009·Updated Apr 11, 2014

In Brief

An observational study for Coronary Artery Disease. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.8 years ago