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Completed

NCT Number: NCT01599741

X-ray Dose Reduction Study for Endovascular Interventional Radiology

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: ClarityIQ

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.

Other names: AlluraXper

Primary outcomes

  1. 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

  1. Radiation Dose Measurements: Dose Area Product (DAP)

    Time frame: 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.

  2. Radiation Dose Measurements: Air Kerma (AK)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2012
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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