RADIQAL Study (Radiation Dose and Image Quality Trial)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
University of Colorado
NOT_YET_RECRUITING
Denver
Georgia
Emory University Hospital
NOT_YET_RECRUITING
Atlanta
New York
NYP Columbia
NOT_YET_RECRUITING
New York
Other Locations
Denmark
Aarhus university hospital
RECRUITING
Aarhus
Spain
Hospital Clinico San Carlos
RECRUITING
Madrid
Contact Information
Primary
Martijn van Mourik
Martijn.van.Mourik@philips.com
+31 (6) 41477135
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 824
Treatments
Experimental: Intervention (Xres5)
treatment with the Azurion system with Xres5
Active_comparator: Control (ClarityIQ)
the standard of care (ClarityIQ/Xres4)
Related Therapeutic Areas
Sponsors
Leads: Philips Clinical & Medical Affairs Global

This content was sourced from clinicaltrials.gov