RADIQAL Study (Radiation Dose and Image Quality Trial)

NCT06944509 | Recruiting FDA Device

• 1 other identifier: IGT-200140-RADIQAL
• Study Type: interventional
• Target: 824
• Locations: 4 countries
• Sites: 6

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.

Conditions

Coronary Artery Disease

Keywords

invasive diagnostic procedures; diagnostic coronary angiographies; percutaneous coronary interventions; invasive coronary angiography; coronary artery disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)

  During study procedure

• Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)

  During study procedure

• Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)

  During study procedure

• Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)

  During study procedure

• Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)

  During study procedure

Other Outcomes (5)

• Staff radiation dose (ClarityIQ vs Xres5)

  During study procedure

• Staff radiation dose (ClarityIQ vs Xres5)

  During study procedure

• Iodine contrast volume administered (ClarityIQ vs Xres5)

  During study procedure

Study Arms (2)

Intervention (Xres5)

EXPERIMENTAL

treatment with the Azurion system with Xres5

Device: treatment with the Azurion system with Xres5

Control (ClarityIQ)

ACTIVE COMPARATOR

the standard of care (ClarityIQ/Xres4)

Other: Azurion with Clairy IQ

Interventions

treatment with the Azurion system with Xres5 DEVICE

treatment with the Azurion system with Xres5

Intervention (Xres5)

Azurion with Clairy IQ OTHER

Azurion system with the standard of care (ClarityIQ/Xres4)

Control (ClarityIQ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (6)

University of Colorado

Denver, Colorado, 80204, United States

NOT YET RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

NYP Columbia

New York, New York, 80045, United States

NOT YET RECRUITING

University Hospital Královské Vinohrady

Prague, Czechia

RECRUITING

Aarhus university hospital

Aarhus, Denmark

RECRUITING

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

Related Publications (7)

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

  BACKGROUND

• 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.

  PMID: 27610932 BACKGROUND

• 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.

  PMID: 25840815 BACKGROUND

• 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.

  PMID: 25471927 BACKGROUND

• 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.

  PMID: 18242136 BACKGROUND

• 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.

  PMID: 9973023 BACKGROUND

• 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.

  PMID: 21435613 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Martijn van Mourik

CONTACT

+31 (6) 41477135; Martijn.van.Mourik@philips.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 25, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); ES (1); CZ (1); US (3)