Coronary Artery Disease
Conditions
Keywords
invasive diagnostic procedures, diagnostic coronary angiographies, percutaneous coronary interventions, invasive coronary angiography, coronary artery disease
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.
Interventions
DEVICEtreatment with the Azurion system with Xres5
treatment with the Azurion system with Xres5
OTHERAzurion with Clairy IQ
Azurion system with the standard of care (ClarityIQ/Xres4)
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient radiation dose and procedural performance (ClarityIQ vs Xres5) | during study procedure | \- Cumulative Dose Area Product (DAP) \[Gycm2\] Total patient group - All procedure types |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5) | During study procedure | \- Cumulative DAP \[Gycm2\] High BMI patients (BMI ≥ 30 kg/m2) - All procedures types |
| Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5) | During study procedure | \- Cumulative DAP \[Gycm2\] Total patient group - ICA procedures |
| Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5) | During study procedure | \- Cumulative DAP \[Gycm2\] Total patient group - PCI and ICA+PCI procedures |
| Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5) | During study procedure | \- Cumulative Cine Air Kerma \[Gy\] Total patient group - All procedure types - Coronary Cine Data |
| Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5) | During study procedure | \- Cumulative Cine Air Kerma \[Gy\] High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data |
| Ultra-low dose cine fluoro rate (Xres5) | During study procedure | \- Air Kerma rate per acquisitions \[mGy/minutes\] Xres5 cases - Total Patient group - All procedure types |
Countries
Czechia, Denmark, Spain, United States
Outcome results
None listed