RADIQAL Study (Radiation Dose and Image Quality Trial) (RADIQAL)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: treatment with the Azurion system with Xres5; Other: Azurion with Clairy IQ

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.

• Study Type: Interventional
• Enrollment (Estimated): 824
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martijn van Mourik; Phone Number: +31 (6) 41477135; Email: Martijn.van.Mourik@philips.com

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • University Hospital Královské Vinohrady
    • Contact: Viktor Prof. Dr. Kočka; Phone Number: (+)420 267162701; Email: viktor.kocka@fnkv.cz
• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Aarhus University Hospital
    • Contact: Nicolaj Prof. Dr. Brejnholt Støttrup; Phone Number: (+)45 27118810; Email: nicostoe@rm.dk
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Javier MD PhD FESC Escaned; Phone Number: +34 917044596; Email: escaned@secardiologia.es
• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Not yet recruiting
      • University of Colorado
      • Contact: Prof. Dr. Messenger; Phone Number: +1 303-315-5969
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University Hospital
      • Contact: William Prof. Dr. Nichelson; Phone Number: +1 404-712-2000; Email: wjnicho@emory.edu
  • New York
    • New York city, New York, United States, 80045
      • Not yet recruiting
      • NYP Columbia
      • Contact: Ajay Prof. Dr. Kirtane; Phone Number: +1 212-305-2500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Xres5); treatment with the Azurion system with Xres5	Device: treatment with the Azurion system with Xres5; treatment with the Azurion system with Xres5
Active Comparator: Control (ClarityIQ); the standard of care (ClarityIQ/Xres4)	Other: Azurion with Clairy IQ; Azurion system with the standard of care (ClarityIQ/Xres4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)	- Cumulative Dose Area Product (DAP) [Gycm2] Total patient group - All procedure types	during study procedure
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)	- Cumulative Air Kerma (AK) [Gy] Total patient group - All procedure types	during study procedure
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)	- Time System in Use* [minutes] Total patient group - All procedure types	during study procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)	- Cumulative DAP [Gycm2] High BMI patients (BMI ≥ 30 kg/m2) - All procedures types	During study procedure
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)	- Cumulative Air Kerma [Gy] High BMI patients (BMI ≥ 30 kg/m2) - All procedures types	During study procedure
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)	- Time System in Use* [minutes] High BMI patients (BMI ≥ 30 kg/m2) - All procedures types	During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)	- Cumulative DAP [Gycm2] Total patient group - ICA procedures	During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)	- Cumulative Air Kerma [Gy] Total patient group - ICA procedures	During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)	- Time System in Use* [minutes] Total patient group - ICA procedures	During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)	- Cumulative DAP [Gycm2] Total patient group - PCI and ICA+PCI procedures	During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)	- Cumulative Air Kerma [Gy] Total patient group - PCI and ICA+PCI procedures	During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)	- Time System in Use* [minutes] Total patient group - PCI and ICA+PCI procedures	During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)	- Cumulative Cine Air Kerma [Gy] Total patient group - All procedure types - Coronary Cine Data	During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)	- Cumulative Cine DAP [Gycm2] Total patient group - All procedure types - Coronary Cine Data	During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)	- Time System in Use* [minutes] Total patient group - All procedure types - Coronary Cine Data	During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)	- Cumulative Cine Air Kerma [Gy] High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data	During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)	- Cumulative Cine DAP [Gycm2] High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data	During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)	- Time System in Use* [minutes] High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data	During study procedure
Ultra-low dose cine fluoro rate (Xres5)	- Air Kerma rate per acquisitions [mGy/minutes] Xres5 cases - Total Patient group - All procedure types	During study procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff radiation dose (ClarityIQ vs Xres5)	- Deep dose Hp(10) [mSv] Total Patient group - All procedure types	During study procedure
Staff radiation dose (ClarityIQ vs Xres5)	- Skin dose Hp(0.07) [mSv] Total Patient group - All procedure types	During study procedure
Iodine contrast volume administered (ClarityIQ vs Xres5)	- Iodinated contrast volume [ml] Total Patient group - All procedure types	During study procedure
Patient Radiation Dose - Projection Angles (ClarityIQ vs Xres5)	- DAP per run [Gycm2] Total Patient group - All procedure types	During study procedure
Patient Radiation Dose - Projection Angles (ClarityIQ vs Xres5)	- Air Kerma per run [Gy] Total Patient group - All procedure types	During study procedure

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Publications and helpful links

General Publications

• 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.
• Philips Medical Systems Nederland B.V., "Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures"
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: coronary artery disease; percutaneous coronary interventions; invasive coronary angiography; invasive diagnostic procedures; diagnostic coronary angiographies
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: IGT-200140-RADIQAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No