Clinical Validation and Evaluation of X-ray Image Processing for Endovascular Digital Subtraction Angiography and Intervention
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Image Quality
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Image Quality
Time Frame: 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 Outcomes
- Radiation Dose Measurements: Air Kerma (AK)(Participants were followed for the duration of the procedure)
- Radiation Dose Measurements: Dose Area Product (DAP)(Participants were followed for the duration of the procedure)