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NCT Number: NCT06260488

Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence

The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules.

There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue.

This microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, 67 091, France

Location status: Recruiting

Location contact

Salomé KUNTZ, Doctor

CONTACT

[email protected]

+31 3 69 55 01 98

About this study

The aim of this study is to evaluate the technical feasibility of histological segmentation by the FPAS algorithm from CT. The results of this study will provide initial data to evaluate the interest of a subsequent larger scale study to validate the diagnostic capabilities of automated segmentation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female of legal age
  • Subject with a planned transfemoral amputation in the vascular surgery department of the Hôpitaux Universitaires de Strasbourg as standard care
  • Subject with a CT as part of standard care
  • Subject who has given his/her non-opposition to participate in the study

Exclusion criteria

  • Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding)

Treatment and study plan

endovascular surgery

Procedure

routine endovascular surgery and FPAS harvesting from amputated limbs to evaluate the technical feasibility of histological segmentation by the FPAS algorithm from CT

Primary outcomes

  1. Assessing the feasibility of histological segmentation of the superficial femoral artery on preoperative microscanner using artificial intelligence

    Time frame: 1 hour

    Rate of slices (in %) for which segmentation is considered sufficient. The quality of segmentation will be assessed by the clinician using a Likert scale.

    Segmentation is considered sufficient if the scale is ≥ 3 and insufficient if it is < 3

Study contacts

Contact information is provided by the study sponsor or research team.

Salomé KUNTZ, Doctor

CONTACT

[email protected]

+31 3 69 55 01 98

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence: a Feasibility Study (CTPred)

Acronym: CTPred

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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