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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Correlation of Stent Diameter Measurements Between the QCA and IVUS . |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients that underwent IVUS guided stent implantation in the institution.
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| Name | Affiliation | Role |
|---|---|---|
| Giora Weisz, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results. | Posted | Number | percentage of correct decisions by SO | On the procedure day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giora Weisz MD | Columbia University Medical Center | 212-305 7060 | gw2128@mail.cumc.columbia.edu |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS |
| On day of procedure |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results. | Posted | Mean | Standard Deviation | mm | On day of procedure |
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| 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. | Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results. | Posted | Number | percentage of correct decision by QCA | On procedure day |
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|
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| 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 | Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results. | Posted | Mean | Standard Deviation | mm | On day of procedure |
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| 0 |
| 40 |
| 0 |
| 40 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |