RADIQAL Study: Comparing X-ray Imaging Systems for Coronary Artery Disease

This study, called the RADIQAL Study, is looking at two different X-ray imaging systems used during heart procedures for people with coronary artery disease (blocked heart arteries). It compares the Azurion system with Xres5 to the standard Azurion system with ClarityIQ (Xres4). Researchers want to see if the new Xres5 system can reduce the amount of radiation you receive and how well the procedure goes. You might be able to join if you are 18 or older, need a diagnostic angiography or coronary intervention, and can give your consent. The study aims to enroll 824 participants. The study's success will be measured by the patient's radiation dose and how well the procedure is performed.

Study design
This is a prospective, randomized study where participants are randomly assigned to one of two groups (1:1 ratio) to receive either the Xres5 or ClarityIQ imaging system. It is an unblinded study, meaning both you and your doctor will know which system is being used.
What's involved
You will be screened, give written consent, and then be randomly assigned to receive treatment with either the Azurion system with Xres5 or the standard of care (ClarityIQ/Xres4). The study procedures end after your coronary procedure is completed.
Compensation
Not stated in the trial record.
Follow-up
There will be no modifications to your standard follow-up care after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06944509

RADIQAL Study (Radiation Dose and Image Quality Trial)

Active, Not Recruiting
NAAges 18+Interventional
Philips Clinical & Medical Affairs Global
~824 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:treatment with the Azurion system with Xres5Azurion with Clairy IQ

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
Measured over during study procedure
+2 more outcomes measured
Coronary Artery Disease
6 sites across 6 states
Colorado1
Georgia1
New York1
Czechia1
Denmark1
Spain1

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).
  • Patient radiation dose and procedural performance (ClarityIQ vs Xres5)during study procedure

    \- Cumulative Dose Area Product (DAP) \[Gycm2\] Total patient group - All procedure types

  • Patient radiation dose and procedural performance (ClarityIQ vs Xres5)during study procedure

    \- Cumulative Air Kerma (AK) \[Gy\] Total patient group - All procedure types

  • Patient radiation dose and procedural performance (ClarityIQ vs Xres5)during study procedure

    \- Time System in Use\* \[minutes\] Total patient group - All procedure types