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

Rennes University Hospital60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Creation of a bone and arterial panorama using EndoNaut® software.PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rennes Univesity Hospital

Rennes, France

Outcomes

Primary Outcomes

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