RADIQAL Study (Radiation Dose and Image Quality Trial) (NCT06944509) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
RADIQAL Study (Radiation Dose and Image Quality Trial)
United States, Czechia, Denmark824 participantsStarted 2025-05-14
Plain-language summary
The Azurion R4.0 is developed by Philips Medical Systems Nederland B.V., a Philips Healthcare company. The Azurion is an interventional X-ray system which is used for live X-ray imaging during invasive cardiac procedures. The proposed Azurion R4.0 includes new x-ray image postprocessing (Xres5) compared to its predecessor, which was equipped with ClarityIQ image post-processing (Xres4).
Azurion R4.0 is a cleared device for EU-MDR regulated countries, submission for FDA510K clearance in the US is pending. Sites in the US will only be activated in the study after FDA clearance.
This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation. Randomization will be 1:1 between Xres5 and ClarityIQ (Xres4). Stratification will be performed per site on intended procedure type (based on clinical presentation) and patient BMI.
Primary objective is to demonstrate that in coronary procedures, Xres5 can reduce overall patient radiation dose compared to the current ClarityIQ without affecting procedural performance.
It is expected that 824 subjects are necessary to collect sufficient data for the evaluation of the objectives of this clinical study. The enrollment period is expected to last for 12 months. The study will be executed in Spain, Czech republic, Denmark and the US.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject will be undergoing a diagnostic angiography and/or coronary intervention /elective PCI.
* Subject is able to give written informed consent.
* Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
Exclusion Criteria:
* Subject with known contrast allergy that cannot be adequately premedicated.
* Subject with previous contraindication for diagnostic angiography and/or diagnostic/elective PCI.
* Subject participates in a potentially confounding drug or device study during the course of the study.
* All vulnerable subjects such as pregnant or breast-feeding women, or any other subject who meets an exclusion criteria according to applicable national laws, if any.
* Subject unwilling or unable to comply with the protocol and/or unable to understand verbal and/or written informed consent.
* Expected use of non-standard contrast concentrations (e.g. dilution of contrast).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this RADIQAL study is comparing two different imaging technologies — ClarityIQ and Xres5 — to see which one lowers the amount of radiation I receive during a heart procedure, does it matter which system my hospital already uses, and could that affect how this study applies to my care?
2This trial is no longer actively enrolling patients — so even if it seemed like a good fit, I couldn't join it now. Given that, are there other ways I can benefit from what this research is testing, such as choosing a hospital or cath lab that already uses lower-dose imaging technology for coronary artery procedures?
3Since this trial is listed as Phase NA, meaning it's studying how equipment performs rather than testing a new drug or treatment, does participating in a study like this carry different risks compared to a standard cardiac procedure, particularly around radiation exposure?
4How does the radiation dose I'd receive during a typical coronary artery procedure at this hospital compare to what's being studied in this trial, and should I be asking specifically about which imaging system my care team uses?
5If I do need a procedure for my coronary artery disease, is radiation dose from imaging something we should actively factor into our decision about where and how I'm treated, especially in light of research like this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
Timeframe: during study procedure
2
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
Timeframe: during study procedure
3
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)