Azurion Imaging System for Coronary Artery Disease
(RADIQAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new X-ray imaging system called Azurion R4.0 for individuals undergoing procedures for coronary artery disease, a condition where the heart's blood vessels narrow. The goal is to determine if this new system can reduce radiation exposure without compromising the procedure's success. Participants will be randomly assigned to use either the new system or the current standard system. Suitable candidates for this trial have scheduled a diagnostic angiography or a planned coronary procedure. The study will be conducted in several countries, including the United States, pending necessary approvals. As an unphased trial, it offers participants the opportunity to contribute to advancements in medical imaging technology.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What prior data suggests that the Azurion Imaging System is safe for coronary artery disease procedures?
Research has shown that the Azurion Imaging System with Xres5 reduces radiation exposure during heart procedures. However, limited direct information exists about its safety in humans from available studies. The Azurion with Xres5 is new and not yet approved in the US, though it is permitted in some European countries, indicating it meets certain safety standards there. Generally, medical devices undergo thorough testing to ensure safety and effectiveness before widespread use.12345
Why are researchers excited about this trial?
Researchers are excited about the Azurion Imaging System with Xres5 for coronary artery disease because it offers advanced imaging capabilities that could improve the precision of coronary interventions. Unlike the standard ClarityIQ system, which uses Xres4 technology, Azurion with Xres5 is expected to provide clearer, more detailed images of the coronary arteries. This enhanced clarity could help cardiologists diagnose and treat blockages more effectively, potentially leading to better patient outcomes.
What evidence suggests that the Azurion Imaging System is effective for coronary artery disease?
Studies have shown that the Azurion system with Xres5, which participants in this trial may receive, greatly reduces X-ray exposure during heart procedures. This new technology uses a very low dose of X-rays, cutting exposure by 50% compared to the lowest settings currently available. Importantly, this reduction in radiation does not affect the quality or success of the procedures. The researchers aim to keep patients safer by lowering radiation risks while still providing clear and effective images for heart treatments. This makes the Azurion with Xres5 a promising advancement for people undergoing procedures for coronary artery disease.24678
Are You a Good Fit for This Trial?
The RADIQAL Study is for individuals with coronary heart disease or cardiomyopathy who are undergoing invasive cardiac procedures. Participants must be suitable for live X-ray imaging and fall within the study's BMI requirements. The trial excludes certain patients based on criteria not specified here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment and Randomization
Baseline assessment and randomization of patients to either the intervention group (Xres5) or the control group (ClarityIQ/Xres4)
Treatment
Treatment with the Azurion system with Xres5 or the standard of care (ClarityIQ/Xres4) during coronary procedures
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azurion with Xres5
Find a Clinic Near You
Who Is Running the Clinical Trial?
Philips Clinical & Medical Affairs Global
Lead Sponsor
Roy Jakobs
Philips Clinical & Medical Affairs Global
Chief Executive Officer since 2022
MBA from Erasmus University Rotterdam
Carla Goulart Peron
Philips Clinical & Medical Affairs Global
Chief Medical Officer since 2023
MD from an unspecified institution