Status:
RECRUITING
RADIQAL Study (Radiation Dose and Image Quality Trial)
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 invasiv...
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 \[inte...
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.
- 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).
Key Trial Info
Start Date :
May 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
824 Patients enrolled
Trial Details
Trial ID
NCT06944509
Start Date
May 14 2025
End Date
December 31 2026
Last Update
July 30 2025
Active Locations (6)
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1
University of Colorado
Denver, Colorado, United States, 80204
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
NYP Columbia
New York, New York, United States, 80045
4
University Hospital Královské Vinohrady
Prague, Czechia