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Contrast Medium Reduction with AlluraClarity for Alliac/Peripheral and EVAR procedures


- candidate number27099
- NTR NumberNTR6312
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-apr-2017
- Secondary IDsXCY607-130043 Philips protocol (study plan) nummer
- Public TitleContrast Medium Reduction with AlluraClarity for Alliac/Peripheral and EVAR procedures
- Scientific TitleContrast Medium Reduction with AlluraClarity for Alliac/Peripheral and EVAR procedures
- ACRONYM
- hypothesisThe goal of the study is to validate the hypothesis that it is possible, based on the relationship between image quality, patient dose and parameters affecting contrast medium, to find a compromise among them in order to reduce the administrered volume of contrast medium injected, at the expense of patient radiation dose, while maintaining clinically acceptable image quality.
- Healt Condition(s) or Problem(s) studiedAbdominal Aortic Aneurysm, Endovascular Procedures
- Inclusion criteria-Subject will be undergoing an EVAR or iliac/peripheral procedure
-Subject is 18 years of age or older, or of legal age to give informed consent per national law
- Exclusion criteria-Subject with contrast allergies
-Subject with severe kidney disease (e-GFR <45 by Modification of Diet in Renal Disease (MDRD formula)
-Subject participates in a potentially confounding drug or device trial during the course of the study.
-Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
-Subject with overt hyperthyroidism
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2017
- planned closingdate1-jun-2019
- Target number of participants260
- InterventionsThe study is divided in 3 phases:
Phase 0: Radiation dose reduction and determination of the optimum reduced dose level. (20 patients for iliac and 20 for EVAR procedures, 40 in total)
Phase 1: Double injection per patient: once with the optimum settings found in phase 0, and the second time with a reduced amount of contrast agent and gradual increase of the radiation dose. The optimum combination of reduced contrast agent and increased radiation will be determined. (20 patients for iliac and 20 for EVAR procedures, 40 in total)
Phase 2: A prospective randomized observational un-blinded single center study using the two optimum settings determined in phases 0 and 1. (90 patients for iliac and 90 for EVAR, 180 in total)
- Primary outcomeCompare the amount of contrast medium required to perform iliac/peripheral and EVAR procedures using the AlluraClarity control settings and the study settings, at similar procedure complexity quantified as fluoro time, number of DSA images and number of DSA runs.
- Secondary outcome-Demonstrate that study settings and diluted contrast medium injection protocols for DSA can be used for an entire procedure (i.e. prove that physician never switches back during the procedure to control settings and standard contrast medium injection protocol)

-Evaluate the change in radiation dose required to minimize contrast medium usage for the new proposed study settings
- TimepointsSubjects are enrolled in the study for the duration of the interventional procedure. No follow-up is required. Patients will be followed according to regular clinical standard of care.

The total duration of the study is expected to take approximately 2 years.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD Mehrsima Abdoli
- CONTACT for SCIENTIFIC QUERIESPhD Mehrsima Abdoli
- Sponsor/Initiator Philips Medical Systems Nederland B.V.
- Funding
(Source(s) of Monetary or Material Support)
Philips Medical Systems Nederland B.V.
- Publications
- Brief summaryThe AlluraClarity is developed by Philips Medical Systems, a Philips Healthcare company. The proposed AlluraClarity is a novel X-ray imaging technology, successor of the previous family of angiography systems, Allura Xper.

Contrast medium induced nephrotoxity is considered an important cause of hospital acquired renal failure. The goal of the study is to validate the hypothesis that it is possible, based on the relationship between image quality, patient dose and parameters affecting contrast medium, to find a compromise among them in order to reduce the administrered volume of contrast medium injected, at the expense of patient radiation dose, while maintaining clinically acceptable image quality.

Principal Investigator: Michiel de Haan, Maastricht University Medical Center
- Main changes (audit trail)
- RECORD14-apr-2017 - 1-jun-2017


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