X-ray Dose Reduction Study for Endovascular Interventional Radiology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Validation and Evaluation of X-ray Image Processing for Endovascular Digital Subtraction Angiography and Intervention

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Radiation: Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.
* Radiation: Normal dose DSA with conventional X-ray imaging technology


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ClarityIQ<br>Low-dose DSA (83% reducation compared to normal dose) with novel X-ray imaging technology. | Radiation: Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.<br>* Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology.<br>* Other names: ClarityIQ;|
| Active Comparator: AlluraXper<br>Normal dose DSA with conventional X-ray imaging technology. | Radiation: Normal dose DSA with conventional X-ray imaging technology<br>* Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology.<br>* Other names: AlluraXper;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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X-rays, Endovascular angiography, Image processing