Comparing two imaging systems for coronary procedures
RADIQAL Study (Radiation Dose and Image Quality Trial)
This study is testing if a new imaging system can help reduce radiation exposure for patients undergoing heart procedures compared to the standard system.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 824 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 6 sites (Denver, Colorado and 5 other locations) |
| Trial ID | NCT06944509 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to compare the Azurion R4.0 imaging system with Xres5 post-processing against the standard ClarityIQ (Xres4) during invasive cardiac procedures. Patients undergoing diagnostic angiography or elective percutaneous coronary interventions will be randomly assigned to one of the two imaging systems. The primary goal is to determine if the Xres5 system can reduce the overall radiation dose received by patients during these procedures. The study will take place across multiple international centers, with data collected on patient characteristics and radiation exposure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for diagnostic angiography or elective PCI.
Not a fit: Patients with known contrast allergies or contraindications for angiography may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced radiation exposure for patients undergoing coronary procedures.
How similar studies have performed: Other studies have shown success with similar imaging approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Denver, Colorado and 5 other locations
- University of Colorado — Denver, Colorado, United States (Not_yet_recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Not_yet_recruiting)
- NYP Columbia — New York, New York, 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)
Study contacts
- Study coordinator: Martijn van Mourik
- Email: Martijn.van.Mourik@philips.com
- Phone: +31 (6) 41477135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.