Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures
Philips (NYSE: PHG) has launched the RADIQAL (Radiation Dose and Image Quality Trial) study to evaluate its new ultra-low X-ray dose technology for coronary procedures. The multicenter trial will enroll 824 patients across 6 hospitals in Spain, Czech Republic, Denmark, and the US, with the first patient enrolled at Aarhus University Hospital, Denmark.
The study aims to compare radiation exposure, image quality, and procedural performance between Philips' new ultra-low dose technology and existing ClarityIQ technology, both integrated into the Azurion image-guided therapy system. The new technology features an ultra-low dose protocol that reduces X-ray exposure by 50% compared to the lowest setting currently available on Azurion systems with ClarityIQ. The technology has received CE marking but is not yet FDA-cleared.
Philips (NYSE: PHG) ha avviato lo studio RADIQAL (Radiation Dose and Image Quality Trial) per valutare la sua nuova tecnologia a dose ultra-bassa di raggi X per procedure coronariche. Lo studio multicentrico arruolerà 824 pazienti in 6 ospedali in Spagna, Repubblica Ceca, Danimarca e Stati Uniti, con il primo paziente arruolato presso l'Ospedale Universitario di Aarhus, Danimarca.
L'obiettivo dello studio è confrontare l'esposizione alle radiazioni, la qualità delle immagini e le prestazioni procedurali tra la nuova tecnologia ultra-bassa dose di Philips e la tecnologia ClarityIQ esistente, entrambe integrate nel sistema di terapia guidata da immagini Azurion. La nuova tecnologia presenta un protocollo a dose ultra-bassa che riduce l'esposizione ai raggi X del 50% rispetto all'impostazione più bassa attualmente disponibile sui sistemi Azurion con ClarityIQ. La tecnologia ha ottenuto la marcatura CE ma non è ancora stata approvata dalla FDA.
Philips (NYSE: PHG) ha lanzado el estudio RADIQAL (Radiation Dose and Image Quality Trial) para evaluar su nueva tecnología de dosis ultra baja de rayos X para procedimientos coronarios. El ensayo multicéntrico inscribirá a 824 pacientes en 6 hospitales en España, República Checa, Dinamarca y Estados Unidos, con el primer paciente inscrito en el Hospital Universitario de Aarhus, Dinamarca.
El estudio tiene como objetivo comparar la exposición a la radiación, la calidad de imagen y el rendimiento del procedimiento entre la nueva tecnología de dosis ultra baja de Philips y la tecnología ClarityIQ existente, ambas integradas en el sistema de terapia guiada por imágenes Azurion. La nueva tecnología cuenta con un protocolo de dosis ultra baja que reduce la exposición a rayos X en un 50% en comparación con la configuración más baja actualmente disponible en los sistemas Azurion con ClarityIQ. La tecnología ha recibido la marca CE pero aún no cuenta con la aprobación de la FDA.
필립스 (NYSE: PHG)는 관상동맥 시술을 위한 새로운 초저선량 X선 기술을 평가하기 위해 RADIQAL(방사선 선량 및 영상 품질 시험) 연구를 시작했습니다. 이 다기관 임상시험은 스페인, 체코, 덴마크, 미국의 6개 병원에서 824명의 환자를 등록할 예정이며, 첫 환자는 덴마크 아루스 대학병원에서 등록되었습니다.
이 연구는 필립스의 새로운 초저선량 기술과 기존 ClarityIQ 기술 간의 방사선 노출, 영상 품질 및 시술 성능을 비교하는 것을 목표로 하며, 두 기술 모두 Azurion 영상 유도 치료 시스템에 통합되어 있습니다. 새로운 기술은 Azurion 시스템의 ClarityIQ에서 현재 제공되는 가장 낮은 설정과 비교하여 X선 노출을 50% 줄이는 초저선량 프로토콜을 특징으로 합니다. 이 기술은 CE 인증을 받았으나 아직 FDA 승인을 받지 않았습니다.
Philips (NYSE : PHG) a lancé l'étude RADIQAL (Radiation Dose and Image Quality Trial) pour évaluer sa nouvelle technologie à très faible dose de rayons X pour les procédures coronariennes. L'essai multicentrique recrutera 824 patients dans 6 hôpitaux en Espagne, République tchèque, Danemark et aux États-Unis, avec le premier patient recruté à l'Hôpital universitaire d'Aarhus, au Danemark.
L'étude vise à comparer l'exposition aux radiations, la qualité d'image et la performance des procédures entre la nouvelle technologie à très faible dose de Philips et la technologie ClarityIQ existante, toutes deux intégrées dans le système de thérapie guidée par l'image Azurion. La nouvelle technologie propose un protocole à très faible dose qui réduit l'exposition aux rayons X de 50% par rapport au réglage le plus bas actuellement disponible sur les systèmes Azurion avec ClarityIQ. Cette technologie a reçu le marquage CE mais n'a pas encore été approuvée par la FDA.
Philips (NYSE: PHG) hat die RADIQAL-Studie (Radiation Dose and Image Quality Trial) gestartet, um seine neue Ultra-Niedrigstrahlendosis-Technologie für koronare Eingriffe zu bewerten. Die multizentrische Studie wird 824 Patienten in 6 Krankenhäusern in Spanien, Tschechien, Dänemark und den USA einschließen, wobei der erste Patient am Universitätsklinikum Aarhus in Dänemark eingeschlossen wurde.
Ziel der Studie ist es, die Strahlenbelastung, Bildqualität und Verfahrensleistung zwischen Philips' neuer Ultra-Niedrigdosis-Technologie und der bestehenden ClarityIQ-Technologie zu vergleichen, die beide im Azurion bildgeführten Therapiesystem integriert sind. Die neue Technologie verfügt über ein Ultra-Niedrigdosis-Protokoll, das die Röntgenstrahlenbelastung um 50% im Vergleich zur derzeit niedrigsten Einstellung auf Azurion-Systemen mit ClarityIQ reduziert. Die Technologie ist CE-zertifiziert, aber noch nicht von der FDA zugelassen.
- New technology reduces X-ray exposure by 50% compared to current lowest setting
- CE marking obtained under EU MDR regulatory framework
- Large-scale study with 824 patients across multiple countries
- Technology not yet FDA-cleared for use in US market
- US enrollment has not started
Insights
Philips' RADIQAL trial evaluating ultra-low X-ray dose technology could strengthen their interventional cardiology position if successful.
Philips has launched the RADIQAL clinical trial to evaluate a new ultra-low dose X-ray technology against its existing ClarityIQ technology for coronary procedures. This large-scale study will enroll 824 patients across 6 international hospitals to generate real-world evidence on radiation dose reduction capabilities.
The most significant aspect is the company's claim that this new technology can reduce X-ray exposure by 50% compared to even the lowest setting currently available on Philips' Azurion systems with ClarityIQ. This represents a substantial advancement in radiation safety if validated through the trial.
From a competitive standpoint, this development is strategically important for Philips in the interventional cardiology space. The technology has already obtained CE marking under the EU MDR framework, giving Philips an early regulatory advantage in European markets. However, it's worth noting the technology hasn't received FDA clearance yet, and US enrollment hasn't begun.
The timing is particularly relevant as radiation safety concerns continue to grow in interventional cardiology, especially for high-BMI patients and those requiring multiple procedures. If successful, this technology could become a key differentiator for Philips against competitors like Siemens Healthineers, GE Healthcare, and Canon Medical in the image-guided therapy systems market.
The involvement of prominent cardiologists as principal investigators, including Dr. Javier Escaned (Professor at Hospital Clínico San Carlos) and Dr. Darshan Doshi (Massachusetts General Hospital), adds clinical credibility to the trial. A positive outcome would likely accelerate adoption of Philips' Azurion systems in catheterization laboratories worldwide.
May 20, 2025
- Prospective, randomized, unblinded, comparative, international, multi-center clinical investigation
- 824 patients across 6 hospitals in Spain, Czech Republic, Denmark and the US
- Primary objective is to demonstrate that the new technology can reduce overall patient radiation dose without affecting coronary procedure performance.
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of the RADIQAL (Radiation Dose and Image Quality Trial) trial. This multicenter, randomized study, sponsored by Philips will enroll 824 coronary artery disease patients across 6 hospitals in Spain, Czech Republic and the US. The first patient in the study was enrolled at Aarhus University Hospital, Denmark.
“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. “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.”
Coronary artery disease (CAD) is the most frequent type of heart disease affecting millions of people worldwide. It is caused by chronic inflammation of the coronary arteries, which may lead to a gradual obstruction or sudden occlusion of blood flow to the heart muscle. Percutaneous coronary intervention (PCI) is a widely used image-guided, minimally invasive procedure to open blocked coronary arteries and treat CAD. Philips Azurion is an image-guided therapy system which is used for live X-ray imaging during such procedures.
The RADIQAL trial evaluates radiation exposure, image quality and procedural performance between Philips’ new ultra-low dose technology and existing ClarityIQ technology, both integrated into the Azurion image-guided therapy system. The new technology features an ultra-low dose protocol for coronary procedures, reducing X-ray exposure by
“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.”
* Not cleared as a medical device in FDA-regulated countries. Enrollment in the US has not started.
For further information, please contact:
Joost Maltha
Philips Global External Relations
Tel.: +31 6 10 55 8116
E-Mail: joost.maltha@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.
Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2024 sales of EUR 18 billion and employs approximately 67,200 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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