Cardiovascular Disease
Conditions
Keywords
X-rays, Endovascular angiography, Image processing
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONLow-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.
Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology.
RADIATIONNormal dose DSA with conventional X-ray imaging technology
Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years of age undergoing digital subtraction angiography for diagnosis or treatment of iliac artery disease.
Exclusion criteria
* Patients not willing or unable to give consent to participate * Patients already involved in a clinical trial * Patients under the age of 18 * Pregnant or breastfeeding women * Patients with kidney disease (eGFR \< 60)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality | 1 Day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dose Measurements: Dose Area Product (DAP) | Participants were followed for the duration of the procedure | 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. |
| Radiation Dose Measurements: Air Kerma (AK) | Participants were followed for the duration of the procedure | 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. |
Countries
Netherlands
Participant flow
Recruitment details
The enrollment of patients occured between July 3 and October 12, 2012
Participants by arm
| Arm | Count |
|---|---|
| Allura-Xper-ClarityIQ DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Allura-Xper-ClarityIQ |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 11 |
| Region of Enrollment Netherlands | 51 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
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.
Time frame: 1 Day
Population: All patients with recorded dose information from the system for both DSA runs were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Allura-Xper-ClarityIQ | Image Quality | 0.96 Proportion of images rated equal/better |
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.
Time frame: Participants were followed for the duration of the procedure
Population: All patients with recorded dose information from the system for both DSA runs were used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allura-Xper-ClarityIQ | Radiation Dose Measurements: Air Kerma (AK) | -83 percentage of dose change | Standard Deviation 5 |
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.
Time frame: Participants were followed for the duration of the procedure
Population: All patients with recorded dose information from the system for both DSA runs were used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allura-Xper-ClarityIQ | Radiation Dose Measurements: Dose Area Product (DAP) | -83 percentage of dose change | Standard Deviation 5 |