Peripheral Arterial Disease
Conditions
Brief summary
To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to procedures performed without EndoNaut.
Detailed description
Peripheral artery disease (PAD) is characterized by a narrowing of the size of arteries, which resulting in a loss of hemodynamic load. Endovascular (or percutaneous) procedures performed at the infrainguinal level (axefemoro-popliteal) are very common in affected patients. Therenva offers a complete and consistent lightweight navigation solution (EndoNaut®) based on artificial intelligence (AI) algorithms, and providing technology accessible to all operating rooms for PAD procedures. The aim of this study is to demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to the procedures performed by EndoNaut.
Interventions
PROCEDUREEndovascular procedure
Creation 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.
Sponsors
CH Libourne
Therenva
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of contrast product used during the routine care procedure (ml) | 1 day At enrollment | Volume are reported in mL |
| Irradiation parameters: evaluation of the Fluoroscopy duration (min) | 1 day At enrollment | Parameter given by the X-ray imaging device |
| Irradiation parameters: dose-area quantification (mGy/m2) | 1 day At enrollment | Parameter given by the X-ray imaging device |
| Irradiation parameters: measurement of air Kerma (mGy) | 1 day At enrollment | Parameter given by the X-ray imaging device |
Countries
France
Outcome results
None listed