Philips Begins Trial of Ultra-Low-Dose X-ray in Coronary Procedures

Philips has begun its multicenter, randomized RADIQAL (Radiation Dose and Image Quality Trial) trial, which will enroll 824 coronary artery disease (CAD) patients at six hospitals in Spain, Czech Republic, and the U.S.

The trial will evaluate radiation exposure, image quality, and procedural performance between Philips’ new ultra-low-dose tech and its existing Clarity IQ, both integrated into the Azurion image-guided therapy system. The new tech has an ultra-low-dose protocol for coronary procedures, lowering X-ray exposure by half compared to Philips’ Azurion systems with Clarity IQ.

The technology is currently approved in the EU via CE marking under the new MDR regulatory framework.

Percutaneous coronary intervention (PCI) is a widely used image-guided, minimally invasive procedure to open blocked coronary arteries and treat CAD. Azurion is an image-guided therapy system used for live X-ray imaging during these procedures.

“The ability to reduce radiation exposure without compromising procedural performance is a key priority in interventional cardiology,” said Dr. Javier Escaned, Professor of Cardiology at Hospital Clínico San Carlos and principal investigator of the RADIQAL trial. “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.”

“Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology,” said Dr. Darshan Doshi, Head of Medical & Clinical at Philips Image-Guided Therapy Devices and Interventional Cardiologist at the Massachusetts General Hospital in Boston, USA. “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.”

Yesterday, the company introduced its VeriSight Pro 3D intracardiac echocardiography (ICE) catheter in Europe. The technology brings real-time 3D imaging inside the heart to help procedures be performed with better clarity, without needing general anesthesia.