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Clinical Trials in France / NCT06260488
Recruiting Not applicable

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

NCT06260488 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-03-15
Last updated
2025-04-25

Condition(s) studied

Peripheral Artery DiseaseFemoropopliteal Stenosis

Investigational drug(s) / intervention(s)

Endovascular surgery

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpitaux Universitaire de Strasbourg Strasbourg Bas-Rhin Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06260488 on ClinicalTrials.gov ↗ ← All trials in France