Azurion Imaging System for Coronary Artery Disease

(RADIQAL Trial)

Recruiting at 6 trial locations

Overseen By Martijn van Mourik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Philips Clinical & Medical Affairs Global

Disqualifiers: Contrast allergy, Pregnant, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

824 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Azurion with Xres5 treatment for coronary artery disease?

The research does not directly mention Azurion with Xres5, but it discusses imaging techniques like cadmium-zinc-telluride (CZT) cameras and MR coronary angiography, which are used to diagnose coronary artery disease. These imaging methods help in accurately detecting heart issues, which can indirectly support the effectiveness of treatments by ensuring they are applied to the right conditions. ^{1 2 3 4 5}

Is the Azurion Imaging System for Coronary Artery Disease safe for humans?

The safety of the Azurion Imaging System, also known as Azurion with Xres5, has not been directly evaluated in the provided research articles. However, the safety of similar stent systems, like the XIENCE V Everolimus Eluting Coronary Stent System, has been studied and found to be generally safe in real-world settings for coronary artery disease. ^{6 7 8 9 10}

How is the Azurion Imaging System treatment for coronary artery disease different from other treatments?

The Azurion Imaging System with Xres5 is unique because it likely involves advanced imaging technology that provides noninvasive, high-quality images of the coronary arteries, potentially reducing the need for invasive X-ray angiography, which carries certain risks. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Eligibility Criteria

The RADIQAL Study is for individuals with coronary heart disease or cardiomyopathy who are undergoing invasive cardiac procedures. Participants must be suitable for live X-ray imaging and fall within the study's BMI requirements. The trial excludes certain patients based on criteria not specified here.

Inclusion Criteria

Subject is able to give written informed consent

I am scheduled for a diagnostic heart vessel examination or treatment.

I am at least 18 years old or of legal age to consent where I live.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment and Randomization

Baseline assessment and randomization of patients to either the intervention group (Xres5) or the control group (ClarityIQ/Xres4)

1 day

1 visit (in-person)

Treatment

Treatment with the Azurion system with Xres5 or the standard of care (ClarityIQ/Xres4) during coronary procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Azurion with Xres5

Trial Overview This trial tests a new version of an interventional X-ray system, Azurion R4.0 with Xres5 technology, against the previous version with ClarityIQ (Xres4). It aims to see if Xres5 can reduce radiation doses during coronary procedures without compromising performance.

Participant Groups

Group I: Intervention (Xres5) Experimental Treatment 1 Intervention

treatment with the Azurion system with Xres5

Group II: Control (ClarityIQ) Active Control 1 Intervention

the standard of care (ClarityIQ/Xres4)

Who Is Running the Clinical Trial?

Philips Clinical & Medical Affairs Global

Lead Sponsor

Trials

61

Recruited

17,600+

Roy Jakobs

Philips Clinical & Medical Affairs Global

Chief Executive Officer since 2022

MBA from Erasmus University Rotterdam

Carla Goulart Peron

Philips Clinical & Medical Affairs Global

Chief Medical Officer since 2023

MD from an unspecified institution

References

1. Germany pubmed.ncbi.nlm.nih.gov

[3-dimensional MR coronary angiography in the navigator technic for the primary diagnosis of coronary heart disease: a comparison with conventional coronary angiography]. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Comparative analysis between myocardial perfusion reserve and maximal ischemia score at single photon emission computed tomography with new-generation cadmium-zinc-telluride cameras. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Accuracy of cadmium-zinc-telluride imaging in detecting single and multivessel coronary artery disease: Is there any gender difference? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of a CZT-based all-purpose SPECT camera and a dedicated CZT cardiac device for myocardial perfusion and functional analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional MR coronary angiography using the navigator technique compared with conventional coronary angiography. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice: patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

New endoluminal technology: efficacy and safety--whose responsibility? [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of twelve-month outcomes after percutanous coronary intervention with everolimus-eluting versus zotarolimus-eluting or sirolimus-eluting stents from the PROENCY (PROmus ENdeavor CYpher) registry. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study). [2015]

11. England pubmed.ncbi.nlm.nih.gov

Simultaneous morphological and biochemical endogenous optical imaging of atherosclerosis. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

Integrating automatic and interactive methods for coronary artery segmentation: let the PACS workstation think ahead. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Assessment and reproducibility of aortic atherosclerosis magnetic resonance imaging: impact of 3-Tesla field strength and parallel imaging. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Multimodality imaging of atherosclerosis (magnetic resonance imaging/computed tomography/positron emission tomography-computed tomography). [2016]

15. South Africa pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the coronary arteries. [2021]