Philips trial to test feasibility of reducing radiation during coronary interventions

Health technology giant Royal Philips is launching a large clinical trial to investigate the possibility of using lower X-ray doses during interventional coronary procedures. 

Philips detailed its plans for the RADIQAL (Radiation Dose and Image Quality Trial) study Tuesday during the EuroPCR conference being held in Paris. The multicenter, randomized study, which will enroll 824 patients across 6 hospitals in Spain, Czech Republic, Denmark and the United States, will analyze the feasibility of dose reduction techniques during percutaneous coronary interventions (PCI). 

The Philips Azurion system is widely used for image guidance for PCIs. It was recently updated with new ultralow dose technology that is said to reduce X-ray exposure by up to 50% during coronary procedures. The new feature has received CE marking and is cleared under the EU MDR regulatory framework. 

Principal investigator of the study, Javier Escaned, MD, PhD, a professor of cardiology at San Carlos Clinical Hospital in Madrid, Spain, described the need for dose reduction techniques that do not compromise image quality as “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,” Escaned said in an announcement. “RADIQAL is designed to generate robust, real-world evidence on whether Philips’ new ultra-low X-ray dose technology can reduce radiation exposure for patients and staff without affecting the quality of coronary procedures.” 

“Reducing radiation exposure while maintaining or improving image quality is one of the most important innovation goals in interventional cardiology,” added Darshan Doshi, MD, head of Medical & Clinical at Philips Image-Guided Therapy Devices and an interventional cardiologist at Massachusetts General Hospital in Boston. “Interventional cardiologists rely on low-dose, high-quality imaging for confident decision-making throughout multiple procedures each day. Also, for patients, especially those with high BMI or with complex conditions requiring repeat interventions, minimizing radiation exposure is increasingly critical.” 

Of note, trial enrollment in the U.S. has not yet started, as the device has not been cleared by the U.S. Food and Drug Administration. The first patient enrolled in the trial is from Denmark. 

Learn more about the trial here.