Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
824 participants
INTERVENTIONAL
2025-05-14
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention (Xres5)
treatment with the Azurion system with Xres5
treatment with the Azurion system with Xres5
treatment with the Azurion system with Xres5
Control (ClarityIQ)
the standard of care (ClarityIQ/Xres4)
Azurion with Clairy IQ
Azurion system with the standard of care (ClarityIQ/Xres4)
Interventions
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treatment with the Azurion system with Xres5
treatment with the Azurion system with Xres5
Azurion with Clairy IQ
Azurion system with the standard of care (ClarityIQ/Xres4)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
* 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).
18 Years
ALL
No
Sponsors
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Philips Clinical & Medical Affairs Global
INDUSTRY
Responsible Party
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Locations
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University of Colorado
Denver, Colorado, United States
Emory University Hospital
Atlanta, Georgia, United States
NYP Columbia
New York, New York, United States
University Hospital Královské Vinohrady
Prague, , Czechia
Aarhus university hospital
Aarhus, , Denmark
Hospital Clinico San Carlos
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Prof. Dr. Messenger
Role: primary
Ajay Prof. Dr. Kirtane
Role: primary
References
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Philips Medical Systems Nederland B.V., "Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures"
Gislason-Lee AJ, Keeble C, Malkin CJ, Egleston D, Bexon J, Kengyelics SM, Blackman D, Davies AG. Impact of latest generation cardiac interventional X-ray equipment on patient image quality and radiation dose for trans-catheter aortic valve implantations. Br J Radiol. 2016 Nov;89(1067):20160269. doi: 10.1259/bjr.20160269. Epub 2016 Sep 29.
Nakamura S, Kobayashi T, Funatsu A, Okada T, Mauti M, Waizumi Y, Yamada S. Patient radiation dose reduction using an X-ray imaging noise reduction technology for cardiac angiography and intervention. Heart Vessels. 2016 May;31(5):655-63. doi: 10.1007/s00380-015-0667-z. Epub 2015 Apr 4.
Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.
Smith IR, Rivers JT. Measures of radiation exposure in cardiac imaging and the impact of case complexity. Heart Lung Circ. 2008 Jun;17(3):224-31. doi: 10.1016/j.hlc.2007.10.004. Epub 2008 Jan 31.
Cusma JT, Bell MR, Wondrow MA, Taubel JP, Holmes DR Jr. Real-time measurement of radiation exposure to patients during diagnostic coronary angiography and percutaneous interventional procedures. J Am Coll Cardiol. 1999 Feb;33(2):427-35. doi: 10.1016/s0735-1097(98)00591-9.
Fetterly KA, Lennon RJ, Bell MR, Holmes DR Jr, Rihal CS. Clinical determinants of radiation dose in percutaneous coronary interventional procedures: influence of patient size, procedure complexity, and performing physician. JACC Cardiovasc Interv. 2011 Mar;4(3):336-43. doi: 10.1016/j.jcin.2010.10.014.
Other Identifiers
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IGT-200140-RADIQAL
Identifier Type: -
Identifier Source: org_study_id
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