Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06260488
Study type Interventional
Source University Hospital, Strasbourg, France
Contact
Status Not yet recruiting
Phase N/A
Start date February 15, 2024
Completion date August 15, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05712395 - The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease N/A
Active, not recruiting NCT04534257 - Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Completed NCT02554266 - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed NCT03921905 - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting NCT06369350 - Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion Early Phase 1
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed NCT02542267 - In-Stent Restenosis Post-Approval Study N/A
Completed NCT02522884 - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular Systemâ„¢ in Femoropoliteal Arteries N/A
Completed NCT02563535 - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia Phase 4
Completed NCT02262949 - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System N/A
Completed NCT02145065 - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r) N/A
Completed NCT02228564 - BARD® Study of LIFESTREAMâ„¢ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Completed NCT01743872 - Optical Imaging Measurement of Intravascular Solution Efficacy Trial N/A
Recruiting NCT01424020 - Walking Estimated Limitation Calculated by History - Study 2 Phase 4
Active, not recruiting NCT01597453 - NOR-SYS: The Norwegian Stroke in the Young Study N/A