Clinical trial NCT06944509: RADIQAL Study (Radiation Dose and Image Quality Trial)
Official title: RADIQAL Study (Radiation Dose and Image Quality Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: invasive diagnostic procedures
diagnostic coronary angiographies
percutaneous coronary interventions
invasive coronary angiography
coronary artery disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2025-04-25
Enrollment: 824
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation.
Primary purpose: OTHER

Brief 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.

Detailed description: The study procedures consist of three main steps: 1) patient screening and written informed consent, 2) baseline assessment and randomization and 3) treatment with the Azurion system with Xres5 \[intervention\] or the standard of care (ClarityIQ/Xres4) \[control\]. Patients will be randomly assigned to either the intervention group or the control group (using the standard of care) in a 1:1 ratio. The coronary procedure will be conducted as per institutional standards and at the discretion of the operator, but the standard image processing will be based on the randomization result. If randomized to the intervention group (Xres5), it will always be possible for the operator to cross over to the standard of care imaging processing (Clarity IQ). For the study sites in EU the primary staff in the intervention room will be wearing electronic staff dosimeters which will log the radiation exposure per staff member per procedure.

After the procedure, characteristics of the patient and procedure are captured in an eCRF. The imaging runs will be uploaded in the cloud after de-identification. After the study the radiation dose (DAP and Air Kerma) will be read out from the system.

The study procedures will end after the coronary procedure is completed. There will be no modifications in the standard of care patient treatment or follow-up.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subject with known contrast allergy that cannot be adequately premedicated.
* Subject with previous contraindication for diagnostic angiography and/or diagnostic/elective PCI.
* Subject participates in a potentially confounding drug or device study during the course of the study.
* All vulnerable subjects such as pregnant or breast-feeding women, or any other subject who meets an exclusion criteria according to applicable national laws, if any.
* Subject unwilling or unable to comply with the protocol and/or unable to understand verbal and/or written informed consent.
* Expected use of non-standard contrast concentrations (e.g. dilution of contrast).

Primary outcomes:
measure: Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
timeFrame: during study procedure
measure: Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
timeFrame: during study procedure
measure: Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
timeFrame: during study procedure
Secondary outcomes:
measure: Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Ultra-low dose cine fluoro rate (Xres5)
timeFrame: During study procedure
Other outcomes:
measure: Staff radiation dose (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Staff radiation dose (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Iodine contrast volume administered (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient Radiation Dose - Projection Angles (ClarityIQ vs Xres5)
timeFrame: During study procedure
measure: Patient Radiation Dose - Projection Angles (ClarityIQ vs Xres5)
timeFrame: During study procedure
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: New York city
country: United States
facility: NYP Columbia
state: New York
city: Prague
country: Czechia
facility: University Hospital Královské Vinohrady
city: Aarhus
country: Denmark
facility: Aarhus university hospital
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References:
citation: Philips Medical Systems Nederland B.V., "Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures"
citation: Gislason-Lee AJ, Keeble C, Malkin CJ, Egleston D, Bexon J, Kengyelics SM, Blackman D, Davies AG. Impact of latest generation cardiac interventional X-ray equipment on patient image quality and radiation dose for trans-catheter aortic valve implantations. Br J Radiol. 2016 Nov;89(1067):20160269. doi: 10.1259/bjr.20160269. Epub 2016 Sep 29.
citation: Nakamura S, Kobayashi T, Funatsu A, Okada T, Mauti M, Waizumi Y, Yamada S. Patient radiation dose reduction using an X-ray imaging noise reduction technology for cardiac angiography and intervention. Heart Vessels. 2016 May;31(5):655-63. doi: 10.1007/s00380-015-0667-z. Epub 2015 Apr 4.
citation: Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.
citation: Smith IR, Rivers JT. Measures of radiation exposure in cardiac imaging and the impact of case complexity. Heart Lung Circ. 2008 Jun;17(3):224-31. doi: 10.1016/j.hlc.2007.10.004. Epub 2008 Jan 31.
citation: Cusma JT, Bell MR, Wondrow MA, Taubel JP, Holmes DR Jr. Real-time measurement of radiation exposure to patients during diagnostic coronary angiography and percutaneous interventional procedures. J Am Coll Cardiol. 1999 Feb;33(2):427-35. doi: 10.1016/s0735-1097(98)00591-9.
citation: Fetterly KA, Lennon RJ, Bell MR, Holmes DR Jr, Rihal CS. Clinical determinants of radiation dose in percutaneous coronary interventional procedures: influence of patient size, procedure complexity, and performing physician. JACC Cardiovasc Interv. 2011 Mar;4(3):336-43. doi: 10.1016/j.jcin.2010.10.014.