Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures
20 Mai 2025 - 2:00PM
UK Regulatory
Philips launches RADIQAL study to generate real-world evidence for
new ultra-low X-ray dose technology in coronary procedures
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 50% compared to even the lowest setting
currently available on our Azurion systems with
ClarityIQ. This technology has obtained CE marking and as such
is cleared under the EU MDR regulatory framework*.
“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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