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ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes, shorter pulses and the introduction of automatic real-time motion compensation in subtraction imaging are used, which are known to positively influence image quality . The final effect on the clinical image quality in peripheral angiography is investigated in this study.
X-ray dose and image quality are related by laws of physics. Low dose and high image quality cannot be achieved at the same time. However, image processing algorithms can help an x-ray system to acquire images with lower dose without influencing image quality or achieving higher image quality with equal dose. The primary aim of this study is to verify if the diagnostic image quality is equal or better when using a significant reduction in X-ray dose for endovascular digital subtraction angiography in combination with a novel imaging technology compared to using normal dose with conventional image technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClarityIQ | Experimental | Low-dose DSA (83% reducation compared to normal dose) with novel X-ray imaging technology. |
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| AlluraXper | Active Comparator | Normal dose DSA with conventional X-ray imaging technology. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology. | Radiation | Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality | Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Dose Measurements: Dose Area Product (DAP) | Percentage dose change of ClarityIQ vs. AlluraXper in DAP calculated by DAP/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper. DAP was measured during the ClarityIQ and AlluraXper runs during the procedure. | Participants were followed for the duration of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco van Strijen, MD | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Ziekenhuis | Nieuwegein | 3430 EM | Netherlands |
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The enrollment of patients occured between July 3 and October 12, 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Allura-Xper-ClarityIQ | DSA acquisition of iliac artery with AlluraXper directly followed by DSA with ClarityIQ |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Allura-Xper-ClarityIQ | DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ |
| 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, Continuous | Mean |
| 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 | Image Quality | Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used. | All patients with recorded dose information from the system for both DSA runs were used. | Posted | Mean | 90% Confidence Interval | Proportion of images rated equal/better | 1 Day |
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Procedure
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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 | Allura-Xper-ClarityIQ | DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thijs Grunhagen | Philips | +31 6 11645166 | thijs.grunhagen@philips.com |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Normal dose DSA with conventional X-ray imaging technology | Radiation | Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology. |
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| Radiation Dose Measurements: Air Kerma (AK) | Percentage dose change of ClarityIQ vs. AlluraXper in AK calculated by AK/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper. AK was measured during the ClarityIQ and AlluraXper runs during the procedure. | Participants were followed for the duration of the procedure |
| 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 | Radiation Dose Measurements: Dose Area Product (DAP) | Percentage dose change of ClarityIQ vs. AlluraXper in DAP calculated by DAP/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper. DAP was measured during the ClarityIQ and AlluraXper runs during the procedure. | All patients with recorded dose information from the system for both DSA runs were used. | Posted | Mean | Standard Deviation | percentage of dose change | Participants were followed for the duration of the procedure |
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| Secondary | Radiation Dose Measurements: Air Kerma (AK) | Percentage dose change of ClarityIQ vs. AlluraXper in AK calculated by AK/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper. AK was measured during the ClarityIQ and AlluraXper runs during the procedure. | All patients with recorded dose information from the system for both DSA runs were used. | Posted | Mean | Standard Deviation | percentage of dose change | Participants were followed for the duration of the procedure |
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