N/A
Completed N=40
Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography
Source: ClinicalTrials.gov NCT00973921 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard. — 100 percentage of correct decisions by SO — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard. |
100 | <0.01 sig |
| PRIMARY The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard. |
74.2 | — |
| SECONDARY Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS . |
0.1 | <0.0001 sig |
| SECONDARY Correlation of Stent Diameter Measurements Between the QCA and IVUS . |
0.3 | 0.0034 sig |
Eligibility Criteria
Inclusion Criteria
- Percutaneous coronary intervention indicated clinically.
- IVUS used as part of the standard procedure.
- Subject must be >=40 yrs.
- Subject must provide written informed consent.
Exclusion Criteria
- Low image quality as determined by the investigator.
- Subject is pregnant or nursing.
- Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.
Data sourced from ClinicalTrials.gov (NCT00973921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.