Philips to study ultralow-dose X-ray protocol for coronary procedures
May 21, 2025
by Gus Iversen, Editor in Chief
Royal Philips has launched a multinational clinical trial to evaluate whether its new ultralow-dose X-ray imaging technology can reduce radiation exposure during coronary procedures without compromising performance or image quality.
The RADIQAL (Radiation Dose and Image Quality Trial) study will enroll 824 patients with coronary artery disease across six hospitals in Spain, the Czech Republic, Denmark and the United States. The first patient was enrolled at Aarhus University Hospital in Denmark.
The prospective, randomized, unblinded trial compares Philips’ new imaging protocol against its existing ClarityIQ technology, both of which are integrated into the Azurion image-guided therapy platform. According to Philips, the new protocol can cut X-ray exposure by up to 50% relative to the lowest dose currently available on Azurion systems with ClarityIQ.
The study’s primary objective is to assess whether the reduction in radiation exposure can be achieved without negatively affecting procedural outcomes or image quality during percutaneous coronary interventions (PCI). PCI is a minimally invasive, image-guided procedure commonly used to open narrowed or blocked coronary arteries in patients with coronary artery disease.
Dr. Javier Escaned, professor of cardiology at Hospital Clínico San Carlos in Madrid and the study’s principal investigator, said, “The ability to reduce radiation exposure without compromising procedural performance is a key priority in interventional cardiology. It is also important to achieve high-quality angiograms when using diluted contrast media as part of ultralow-contrast procedures.”
The technology under evaluation has received CE marking in Europe but is not yet cleared for use as a medical device in the United States. Enrollment in the U.S. sites has not yet begun.
Dr. Darshan Doshi, interventional cardiologist at Massachusetts General Hospital and head of medical and clinical affairs at Philips Image-Guided Therapy Devices, emphasized the clinical importance of balancing radiation safety with image quality. “Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology,” he said.
The RADIQAL (Radiation Dose and Image Quality Trial) study will enroll 824 patients with coronary artery disease across six hospitals in Spain, the Czech Republic, Denmark and the United States. The first patient was enrolled at Aarhus University Hospital in Denmark.
The prospective, randomized, unblinded trial compares Philips’ new imaging protocol against its existing ClarityIQ technology, both of which are integrated into the Azurion image-guided therapy platform. According to Philips, the new protocol can cut X-ray exposure by up to 50% relative to the lowest dose currently available on Azurion systems with ClarityIQ.
The study’s primary objective is to assess whether the reduction in radiation exposure can be achieved without negatively affecting procedural outcomes or image quality during percutaneous coronary interventions (PCI). PCI is a minimally invasive, image-guided procedure commonly used to open narrowed or blocked coronary arteries in patients with coronary artery disease.
Dr. Javier Escaned, professor of cardiology at Hospital Clínico San Carlos in Madrid and the study’s principal investigator, said, “The ability to reduce radiation exposure without compromising procedural performance is a key priority in interventional cardiology. It is also important to achieve high-quality angiograms when using diluted contrast media as part of ultralow-contrast procedures.”
The technology under evaluation has received CE marking in Europe but is not yet cleared for use as a medical device in the United States. Enrollment in the U.S. sites has not yet begun.
Dr. Darshan Doshi, interventional cardiologist at Massachusetts General Hospital and head of medical and clinical affairs at Philips Image-Guided Therapy Devices, emphasized the clinical importance of balancing radiation safety with image quality. “Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology,” he said.