Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Coronary Artery Disease

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

FieldValue
Enrollment Target 824 participants
Start Date 2025-05-14
Est. Completion 2026-12-31
Phase NA

Sponsor

Philips Clinical & Medical Affairs Global

45 total trials

Interested in This Trial?

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, categorized as NA. The registered enrollment target is 824 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (36% lower). The listed sponsor is Philips Clinical & Medical Affairs Global, which has 45 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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.

Learn More About Clinical Trials

Similar trials for Coronary Artery Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Coronary Artery Disease

All registered trials for this condition

Colorado

All trials with a study site in Colorado

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.