Peripheral Arterial Disease
Conditions
Keywords
Occlusive arthritis, bone panorama, arterial panorama
Brief summary
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
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.
Interventions
PROCEDURECreation of a bone and arterial panorama using EndoNaut® software.
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.
Sponsors
Rennes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of the registration errors | At the inclusion day | The 2D-2D registration is driven by an error index (intrinsic software criterion) given by the software at the end of the registration process |
| Volume of contrast product used during the routine care procedure (ml) | At the inclusion day | Volume are reported in mL |
| Irradiation parameters: evaluation of the Fluoroscopy duration (min) | At the inclusion day | Parameter given by the X-ray imaging device |
| Irradiation parameters: dose-area quantification (mGy/m2) | At inclusion | Parameter given by the X-ray imaging device |
| Irradiation parameters: measurement of air Kerma (mGy) | At the inclusion day | Parameter given by the X-ray imaging device |
| Irradiation parameters: evaluation of the number of required angiograms | At the inclusion day | Parameter given by the X-ray imaging device |
| Operating time (min) | At the inclusion day | Delay between the beginning (patient anesthesia) and the end (patient transferred to post interventional care room) of the procedure |
Countries
France
Outcome results
None listed