Coronary Artery Disease
Conditions
Keywords
Stent, under-expansion, StentOp, StentOptimizer, IVUS, IC-PRO, image enhancement
Brief 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.
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
Interventions
None listed
Sponsors
Paieon Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard. | 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. |
| The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS . | On day of procedure | The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS. |
| Correlation of Stent Diameter Measurements Between the QCA and IVUS . | On day of procedure | The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | IVUS results were not available | 9 |
Baseline characteristics
| Characteristic | Coronary Stenting Evaluation With IVUS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 28 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 62.2 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: On procedure day
Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coronary Stenting Evaluation With IVUS | The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard. | 74.2 percentage of correct decision by QCA |
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.
Time frame: On the procedure day
Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coronary Stenting Evaluation With IVUS | 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 |
Comparison: The 95% confidence Interval (CI) of the primary outcome has been calculated using the Wilson method of estimating the CI of a single proportionp-value: <0.0195% CI: [0.86, 1]Wilson
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
Time frame: On day of procedure
Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coronary Stenting Evaluation With IVUS | Correlation of Stent Diameter Measurements Between the QCA and IVUS . | 0.3 mm | Standard Deviation 0.4 |
p-value: 0.0034Bland-Altman
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.
Time frame: On day of procedure
Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coronary Stenting Evaluation With IVUS | Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS . | 0.1 mm | Standard Deviation 0.4 |
p-value: <0.0001Bland Altman