RADIQAL Study (Radiation Dose and Image Quality Trial)

Part of paid clinical trials in Denver, Colorado.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT06944509
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • treatment with the Azurion system with Xres5 — DEVICE
    treatment with the Azurion system with Xres5
  • Azurion with Clairy IQ — OTHER
    Azurion system with the standard of care (ClarityIQ/Xres4)

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Jul 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
824 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention (Xres5)
    treatment with the Azurion system with Xres5
  • Active Comparator: Control (ClarityIQ)
    the standard of care (ClarityIQ/Xres4)

Primary Outcome Measure

Patient radiation dose and procedural performance (ClarityIQ vs Xres5) [ Time Frame: during study procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of ColoradoDenverColorado80204
Prof. Dr. Messenger
+1 303-315-5969
Emory University HospitalAtlantaGeorgia30322
William Prof. Dr. Nichelson
[email protected]
+1 404-712-2000
NYP ColumbiaNew YorkNew York80045
Ajay Prof. Dr. Kirtane
+1 212-305-2500

Find similar trials in Denver, CO

By research site
University of Colorado· Denver, COEmory University Hospital· Atlanta, GANYP Columbia· New York, NY

Related Studies