RADIQAL Study (Radiation Dose and Image Quality Trial)

Condition(s) studied

Investigational drug(s) / intervention(s)

treatment with the Azurion system with Xres5: treatment with the Azurion system with Xres5

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Patient radiation dose and procedural performance (ClarityIQ vs Xres5) — during study procedure
  \- Cumulative Dose Area Product (DAP) \[Gycm2\] Total patient group - All procedure types
• Patient radiation dose and procedural performance (ClarityIQ vs Xres5) — during study procedure
  \- Cumulative Air Kerma (AK) \[Gy\] Total patient group - All procedure types
• Patient radiation dose and procedural performance (ClarityIQ vs Xres5) — during study procedure
  \- Time System in Use\* \[minutes\] Total patient group - All procedure types

Trial sites (6)

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