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NCT06944509 · ClinicalTrials.gov registry record · NA
RADIQAL Study (Radiation Dose and Image Quality Trial)
A NA study of Coronary Artery Disease, sponsored by Philips Clinical & Medical Affairs Global.
- Recruiting
- Registry status
- NA
- Development phase
- 824
- Enrollment target
- 6
- Study locations
NCT06944509: Recruiting NA study of Coronary Artery Disease, sponsored by Philips Clinical & Medical Affairs Global.
NCT06944509 is a NA study of Coronary Artery Disease that is actively recruiting participants, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 824 participants, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (36% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06944509, a NA study of Coronary Artery Disease, is actively recruiting participants, sponsored by Philips Clinical & Medical Affairs Global.
- RECRUITING
- Registry status
- NA
- Development phase
- 824 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
\- Cumulative Dose Area Product (DAP) \[Gycm2\] Total patient group - All procedure types
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 |
What NCT06944509 shows while recruiting
NCT06944509 is an interventional study that assigns participants to a tested intervention. The registered 824 participants enrollment target is mid-sized for trials with a published cap, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (36% lower).
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.
NCT06944509 lists 6 locations in 4 states (Other, Colorado, Georgia).
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.
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).
Who is sponsoring clinical trial NCT06944509?
This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT06944509's enrollment target sits among peer trials
824 55th of 219 higher than 165 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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