Comparison of a Full Automatic Software With Standard Methods of Vessels Analysis

NCT05920317 | Unknown

• 1 other identifier: PRAEVA-2-LP_CIP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. The main objectif is to validate the accuracy of the software by demonstrating its adequacy to the standard method of analysis. The second objectives are the following:

• Evaluate the security of the software PRAEVAorta® 2
• Evaluate the unanticipated risks related to the use of the software
• Validate the accessory PRAEVAorta® Web We make the following assumption : 90% of the patients show 90% of adequacy to the healthcare professional analysis

Conditions

Abdominal Aortic Aneurysm

Keywords

Aneurysm; AAA; software; Automatic; Scan

Outcome Measures

Primary Outcomes (6)

• Orthogonal maximum diameter of the aorta (mm)

  3 months

• Thoraco-Aortic lengths of the aorta (mm)

  * Proximal neck length * Infrarenal Aortic length * Left common Iliac artery length * Right common Iliac artery length

  3 months

• Infrarenal volume of the aorta (cm3)

  * Volume circulating * Intraluminal thrombus volume * Total volume

  3 months

• Aorta and iliacs diameters at several places (mm)

  * Aortic diameter above the uppermost renal artery * Upper proximal Neck Diameter * Neck Diameter 5mm under the lower renal * Neck Diameter 10mm under the lower renal * Neck Diameter 15mm under the lower renal * Neck diameter 20mm under the lower renal * Lower proximal Neck Diameter * Proximal right common Iliac artery Diameter * Middle right common iliac artery Diameter * Distal right common Iliac artery Diameter * Distal right external iliac artery Diameter * Proximal left common Iliac artery Diameter * Middle left common iliac artery Diameter * Distal left common iliac artery Diameter * Distal left external Iliac Diameter * Aortic bifurcation diameter

  3 months

• Suprarenal angulation (in degree)

  Angle between the suprarenal aorta and the neck

  3 months

• Infrarenal angulation (in degree)

  Angle between the neck and aneurysm

  3 months

Secondary Outcomes (5)

• Healthcare professional trust questionnaire

  2 days

• Scan analyse time from segmentation to measurements

  3 months

• Unanticipated risks

  3 days

• Number of male and female

  1 day

• Number of patient per age

  1 day

Study Arms (1)

Principal group

Analysis of the CT scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with diagnosed or suspicion of an abdominal aortic aneurysm.

You may qualify if:

• Male or female patients diagnosed with an infrarenal AAA and treated with EVAR at the University Hospital of Leipzig between 2015-2021
• Patient equal to or over 18 years old

You may not qualify if:

• Patients with
• para-renal or thoraco-abdominal aortic aneurysms,
• associated iliac artery aneurysms,
• ruptured aneurysms,
• aortic dissections,

Sponsors & Collaborators

• Nurea: lead
• Universitätsklinikum Leipzig: collaborator

Study Sites (1)

Universitätsklinikum leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (47)

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MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Daniela Dr. Med. BRANZAN

  UNIVERSITY CLINIC LEIPZIG AöR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lamia STEPHAN

CONTACT

+33623247358; lamia.stephan@nurea-soft.com

Florian BERNARD

CONTACT

+33672019591; florian.bernard@nurea-soft.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: June 27, 2023
• Study Start: June 16, 2023
• Primary Completion: November 28, 2023
• Study Completion: December 28, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)