New X-Ray tech aims to slash radiation for heart patients
NCT ID NCT06944509
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new X-ray system (Azurion R4.0) to an older version during heart procedures like angiography. The goal is to see if the new system lowers the radiation dose patients receive while still allowing doctors to work effectively. About 824 adults from several countries will take part, and the results will help improve safety in cardiac care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 824 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus university hospital
Aarhus, Denmark
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Emory University Hospital
Atlanta, Georgia, 30322, United States
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Hospital Clinico San Carlos
Madrid, Spain
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NYP Columbia
New York, New York, 80045, United States
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University Hospital Královské Vinohrady
Prague, Czechia
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University of Colorado
Denver, Colorado, 80204, United States
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