AMSTERDAM (dpa-AFX) - Royal Philips (PHG) Tuesday announced that it has initiated the RADIQAL (Radiation Dose and Image Quality Trial), a multicenter, randomized clinical study focused on evaluating a new ultra-low X-ray dose technology for coronary procedures.
The trial will include 824 patients with coronary artery disease (CAD) across six hospitals located in Spain, the Czech Republic, and the United States. The first participant was enrolled at Aarhus University Hospital in Denmark.
The RADIQAL trial aims to assess radiation exposure, image quality, and procedural performance by comparing Philips' latest ultra-low dose protocol with the existing ClarityIQ technology, both integrated into the company's Azurion image-guided therapy system. This new protocol reportedly reduces X-ray exposure by 50 percent compared to the lowest available setting in current Azurion systems with ClarityIQ. The technology has received CE marking under the EU MDR framework but is not yet approved for use in the U.S.
CAD, a leading form of heart disease, is caused by chronic inflammation and blockages in the coronary arteries. It is commonly treated using image-guided, minimally invasive procedures like percutaneous coronary intervention (PCI), which relies heavily on X-ray imaging systems such as Azurion.
Dr. Javier Escaned, principal investigator from Hospital Clínico San Carlos, emphasized the importance of minimizing radiation exposure in interventional cardiology without compromising the quality of procedures. He stated that the RADIQAL trial aims to generate real-world data on whether Philips' new technology can achieve this balance, particularly during ultra-low contrast angiograms.
Dr. Darshan Doshi, Head of Medical & Clinical at Philips and interventional cardiologist at Massachusetts General Hospital, highlighted that lowering radiation while maintaining high-quality imaging is a key innovation goal. He noted that consistent low-dose, high-quality imaging is crucial for clinicians' decision-making, especially in complex or repeated procedures and for patients with higher BMI.
PHG is currently trading at $23.96, or 0.38% higher on the NYSE.
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