RADIQAL Study (Radiation Dose and Image Quality Trial)

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

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).

Conditions2

Locations3 sites

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