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.
Coronary Artery Disease
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.
RADIQAL Study (Radiation Dose and Image Quality Trial)
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University of Colorado, Denver, Colorado, United States, 80204
Emory University Hospital, Atlanta, Georgia, United States, 30322
NYP Columbia, New York city, New York, United States, 80045
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Philips Clinical & Medical Affairs Global,
2026-12-31