Royal Philips has initiated the RADIQAL (Radiation Dose and Image Quality Trial) study, a multicenter, randomised trial to evaluate radiation exposure and image quality in coronary procedures.
The trial will involve 824 patients with coronary artery disease (CAD) across six hospitals in Spain, the Czech Republic, and the US. The first patient was enrolled at Aarhus University Hospital in Denmark.
Hospital Clínico San Carlos cardiology professor and principal investigator Dr Javier Escaned 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 ultra-low contrast procedures.
“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.”
CAD, the most common form of heart disease, results from chronic inflammation of the coronary arteries, potentially leading to blood flow obstruction to the heart, said Philips.
Percutaneous coronary intervention (PCI), a minimally invasive procedure, is frequently used to treat CAD by opening blocked arteries. Philips’ Azurion system provides live X-ray imaging during such procedures.
The RADIQAL trial will compare Philips’ new ultra-low dose technology with the existing ClarityIQ technology, both integrated into the Azurion system.
The new protocol aims to cut X-ray exposure by 50% compared to the lowest setting currently available on Azurion systems with ClarityIQ. This technology has received CE marking, indicating compliance with the EU MDR regulatory standards.
Philips Image-Guided Therapy Devices medical & clinical head Dr Darshan Doshi said: “Reducing radiation exposure while maintaining or improving image quality is one of the most important innovation goals in interventional cardiology.
“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, minimising radiation exposure is increasingly critical.”
Earlier this week, Philips introduced the VeriSight Pro 3D Intracardiac Echocardiography (ICE) catheter in Europe to support minimally invasive heart procedures. This catheter enables real-time 3D imaging within the heart, enhancing procedural clarity without requiring general anaesthesia.
