Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.

Study Overview
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Brief Summary
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Pilot study to assess the feasibility of creation of a bone and arterial panorama by 2D-2D registration technique during endovascular femoro-popliteal procedures with a mobile C-arm X-ray system using EndoNaut® software.

Detailed Description
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The aim of this study is to show that it is possible to give a complete image of the area to be operated by the surgeon by creating a complete bone and arterial panorama of the femoro-popliteal axis with 2D-2D registration techniques. This study should have a clinical impact for the patient and caregiver. With this technique, we expect a reduction in the irradiation of the patient and the caregivers, a decrease in the volume of injected contrast product and a decrease in operating time.

Official Title
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Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Creation of a bone and arterial panorama using EndoNaut® software.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with peripheral arterial disease of the lower limbs, all clinical stages, lesions of the femoro-popliteal stage and candidates for endovascular treatment of these lesions. Major patients Patients not opposed to their participation in the study Exclusion Criteria: Patients requiring conventional surgical revascularization. Patient under legal protection (guardianship, safeguard of justice). Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic occlusive arthritis of the Lower Limbs<br>Patients with chronic occlusive arthritis of the Lower Limbs with lesions on the femoro-popliteal stage and candidates for endovascular treatment of these lesions. Creation of a bone and arterial panorama using EndoNaut® software. | Procedure: Creation of a bone and arterial panorama using EndoNaut® software.<br>* The routine care procedure begins with staged injections of contrast medium to provide a map of the lesions. The lesions are then treated by angioplasty with or without stenting. New injections of contrast product are made to control the results of the treatment. As part of this pilot study, the assistive software and its interface will be linked and with the mobile C-arm X-ray system. Scopic images and angiograms will be retransmitted to be processed by the EndoNaut® software.<br>* Other names: EndoNaut® software.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the registration errors | The 2D-2D registration is driven by an error index (intrinsic software criterion) given by the software at the end of the registration process | At the inclusion day | 
| Volume of contrast product used during the routine care procedure (ml) | Volume are reported in mL | At the inclusion day | 
| Irradiation parameters: evaluation of the Fluoroscopy duration (min) | Parameter given by the X-ray imaging device | At the inclusion day | 
| Irradiation parameters: dose-area quantification (mGy/m2) | Parameter given by the X-ray imaging device | At inclusion | 
| Irradiation parameters: measurement of air Kerma (mGy) | Parameter given by the X-ray imaging device | At the inclusion day | 
| Irradiation parameters: evaluation of the number of required angiograms | Parameter given by the X-ray imaging device | At the inclusion day | 
| Operating time (min) | Delay between the beginning (patient anesthesia) and the end (patient transferred to post interventional care room) of the procedure | At the inclusion day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occlusive arthritis, bone panorama, arterial panorama