Royal Philips has launched a multicenter study called RADIQAL (Radiation Dose and Image Quality Trial) to test its new ultralow x-ray dose technology for coronary procedures, with the first participants now enrolled.
The study will enroll 824 coronary artery disease (CAD) patients from six hospitals in Spain, the Czech Republic, and the U.S., although the first participant was enrolled from Aarhus University Hospital in Denmark.
The trial will evaluate radiation exposure, image quality, and procedural performance, comparing Philips’ new ultralow dose technology and its existing ClarityIQ, with both integrated into the company’s Azurion image-guided system, the company said.
The new technology has obtained CE marking, but is not yet cleared by the U.S. Food and Drug Administration (FDA). Philips noted that U.S. trial enrollment has not started yet.
