Retrospective Study of the Use of PRAEVAorta 2 Software for Vessel Geometric Analysis Versus Standard Analysis Methods in Patients With Abdominal Aortic Aneurysm

The study PRAEVA-2-LP is realized in the University hospital of Leipzig. The treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure. They demand training and practice. Nurea is developing a software for automatic measurement of these indicators, PRAEVAorta® 2, to facilitate and assist the physician in his clinical routine.

The purpose of this study is to compare the analysis realised by the software PRAEVAorta® 2 with the analysis realised by the healthcare professional on retrospective CT scan images.

Contrasted and non-contrasted, pre-operation or post-operation CT scans from 50 patients will be analysed.

We make the following assumption: 90% of the patients show 90% of adequacy to the healthcare professional analysis

This study is comparative, retrospective, non-interventional and monocentric. We compare the SaMD measurements to measurements realised using the standard method by a healthcare professional. The study analysis retrospective pseudonymised CT scans and deliver aggregated data. The study will be realised on a group of 50 subjects, which is small enough to have one site of investigation. Subjects will be their own witness. This strategy allows us to minimize the cost and the risks of the study without compromising the investigation. This investigation is submitted to the local ethics committee for approval according to paragraph 15 of Professional Code of the Saxon State Medical Association (Berufsordnung - BO) of 24 June 1998.