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NCT Number: NCT06944509

RADIQAL Study (Radiation Dose and Image Quality Trial)

The Azurion R4.0 is developed by Philips Medical Systems Nederland B.V., a Philips Healthcare company. The Azurion is an interventional X-ray system which is used for live X-ray imaging during invasive cardiac procedures. The proposed Azurion R4.0 includes new x-ray image postprocessing (Xres5) compared to its predecessor, which was equipped with ClarityIQ image post-processing (Xres4).

Azurion R4.0 is a cleared device for EU-MDR regulated countries, submission for FDA510K clearance in the US is pending. Sites in the US will only be activated in the study after FDA clearance.

This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation. Randomization will be 1:1 between Xres5 and ClarityIQ (Xres4). Stratification will be performed per site on intended procedure type (based on clinical presentation) and patient BMI.

Primary objective is to demonstrate that in coronary procedures, Xres5 can reduce overall patient radiation dose compared to the current ClarityIQ without affecting procedural performance.

It is expected that 824 subjects are necessary to collect sufficient data for the evaluation of the objectives of this clinical study. The enrollment period is expected to last for 12 months. The study will be executed in Spain, Czech republic, Denmark and the US.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Královské Vinohrady, Prague, Czechia

Loading trial locations.

About this study

The study procedures consist of three main steps: 1) patient screening and written informed consent, 2) baseline assessment and randomization and 3) treatment with the Azurion system with Xres5 [intervention] or the standard of care (ClarityIQ/Xres4) [control]. Patients will be randomly assigned to either the intervention group or the control group (using the standard of care) in a 1:1 ratio. The coronary procedure will be conducted as per institutional standards and at the discretion of the operator, but the standard image processing will be based on the randomization result. If randomized to the intervention group (Xres5), it will always be possible for the operator to cross over to the standard of care imaging processing (Clarity IQ). For the study sites in EU the primary staff in the intervention room will be wearing electronic staff dosimeters which will log the radiation exposure per staff member per procedure.

After the procedure, characteristics of the patient and procedure are captured in an eCRF. The imaging runs will be uploaded in the cloud after de-identification. After the study the radiation dose (DAP and Air Kerma) will be read out from the system.

The study procedures will end after the coronary procedure is completed. There will be no modifications in the standard of care patient treatment or follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject will be undergoing a diagnostic angiography and/or coronary intervention /elective PCI.
  • Subject is able to give written informed consent.
  • Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.

Exclusion criteria

  • Subject with known contrast allergy that cannot be adequately premedicated.
  • Subject with previous contraindication for diagnostic angiography and/or diagnostic/elective PCI.
  • Subject participates in a potentially confounding drug or device study during the course of the study.
  • All vulnerable subjects such as pregnant or breast-feeding women, or any other subject who meets an exclusion criteria according to applicable national laws, if any.
  • Subject unwilling or unable to comply with the protocol and/or unable to understand verbal and/or written informed consent.
  • Expected use of non-standard contrast concentrations (e.g. dilution of contrast).

Treatment and study plan

treatment with the Azurion system with Xres5

Device

treatment with the Azurion system with Xres5

Azurion with Clairy IQ

Other

Azurion system with the standard of care (ClarityIQ/Xres4)

Primary outcomes

  1. Patient radiation dose and procedural performance (ClarityIQ vs Xres5)

    Time frame: during study procedure

    • Cumulative Dose Area Product (DAP) [Gycm2]

    Total patient group - All procedure types

  2. Patient radiation dose and procedural performance (ClarityIQ vs Xres5)

    Time frame: during study procedure

    • Cumulative Air Kerma (AK) [Gy]

    Total patient group - All procedure types

  3. Patient radiation dose and procedural performance (ClarityIQ vs Xres5)

    Time frame: during study procedure

    • Time System in Use* [minutes]

    Total patient group - All procedure types

Secondary outcomes

  1. Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative DAP [Gycm2]

    High BMI patients (BMI ≥ 30 kg/m2) - All procedures types

  2. Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative Air Kerma [Gy]

    High BMI patients (BMI ≥ 30 kg/m2) - All procedures types

  3. Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Time System in Use* [minutes]

    High BMI patients (BMI ≥ 30 kg/m2) - All procedures types

  4. Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative DAP [Gycm2]

    Total patient group - ICA procedures

  5. Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative Air Kerma [Gy]

    Total patient group - ICA procedures

  6. Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Time System in Use* [minutes]

    Total patient group - ICA procedures

  7. Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative DAP [Gycm2]

    Total patient group - PCI and ICA+PCI procedures

  8. Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative Air Kerma [Gy]

    Total patient group - PCI and ICA+PCI procedures

  9. Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Time System in Use* [minutes]

    Total patient group - PCI and ICA+PCI procedures

  10. Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative Cine Air Kerma [Gy]

    Total patient group - All procedure types - Coronary Cine Data

  11. Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative Cine DAP [Gycm2]

    Total patient group - All procedure types - Coronary Cine Data

  12. Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Time System in Use* [minutes]

    Total patient group - All procedure types - Coronary Cine Data

  13. Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative Cine Air Kerma [Gy]

    High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data

  14. Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Cumulative Cine DAP [Gycm2]

    High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data

  15. Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Time System in Use* [minutes]

    High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data

  16. Ultra-low dose cine fluoro rate (Xres5)

    Time frame: During study procedure

    • Air Kerma rate per acquisitions [mGy/minutes]

    Xres5 cases - Total Patient group - All procedure types

Other outcomes

  1. Staff radiation dose (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Deep dose Hp(10) [mSv]

    Total Patient group - All procedure types

  2. Staff radiation dose (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Skin dose Hp(0.07) [mSv]

    Total Patient group - All procedure types

  3. Iodine contrast volume administered (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Iodinated contrast volume [ml]

    Total Patient group - All procedure types

  4. Patient Radiation Dose - Projection Angles (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • DAP per run [Gycm2]

    Total Patient group - All procedure types

  5. Patient Radiation Dose - Projection Angles (ClarityIQ vs Xres5)

    Time frame: During study procedure

    • Air Kerma per run [Gy]

    Total Patient group - All procedure types

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Acronym: RADIQAL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2025
Registry last updated
Jun 12, 2026

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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