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

The 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

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.

Subjects 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.

The 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)