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RADIQAL Study (Radiation Dose and Image Quality Trial)
NCT06944509 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE treatment with the Azurion system with Xres5
- OTHER Azurion with Clairy IQ
Study Locations (6)
Other
- University Hospital Královské Vinohrady — Prague
- Aarhus university hospital — Aarhus
- Hospital Clinico San Carlos — Madrid
Colorado
- University of Colorado — Denver
Georgia
- Emory University Hospital — Atlanta
New York
- NYP Columbia — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 824 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06944509
The ClinicalTrials.gov registry entry for NCT06944509 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 824 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Philips Clinical & Medical Affairs Global, which has 186 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which treatment with the Azurion system with Xres5 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06944509 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Other, Colorado, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06944509 about?
NCT06944509 is a clinical study titled "RADIQAL Study (Radiation Dose and Image Quality Trial)". 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) comp...
What is the current status of trial NCT06944509?
This trial is currently recruiting. It is a NA study. The enrollment target is 824 participants. The study started on 2025-05-14. Estimated completion is 2026-12-31.
What conditions does trial NCT06944509 study?
This clinical trial studies the following conditions: Coronary Artery Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06944509?
The interventions under investigation include: treatment with the Azurion system with Xres5 (DEVICE), Azurion with Clairy IQ (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06944509?
This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 186 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06944509 being conducted?
This trial has 6 study locations across Colorado, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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