Aortic Aneurysm, Iliac Aneurysm, Iliac Artery Stenosis, Stenoses, Aortic
Conditions
Brief summary
The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.
Detailed description
Minimally invasive endovascular interventions are increasingly replacing conventional surgeries, and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy. Therenva offers a comprehensive and consistent lightweight navigation solution (EndoNaut®) for endovascular procedures. This navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase. This information is rendered in augmented reality using artificial intelligence algorithms and digital simulation. This alternative solution to a hybrid room, but which offers equivalent functionality, is compatible with all operating rooms, regardless of the interventional environment. Benefits of imaging fusion remain to be assessed on a larger scale. The aim of this multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.
Interventions
PROCEDUREAorto-iliac endovascular procedure
Percutaneous procedure with stent placement
Sponsors
Rennes University Hospital
Douai hospital
Centre Hospitalier Universitaire Dijon
University Hospital, Brest
Polyclinique Bordeaux Nord Aquitaine
Therenva
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis * Suitable for endovascular repair * 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) | At enrollment | Volume are reported in mL |
| Irradiation parameters: evaluation of the Fluoroscopy duration (min) | At enrollment | Parameter given by the X-ray imaging device |
| Irradiation parameters: dose-area quantification (mGy/m2) | At enrollment | Parameter given by the X-ray imaging device |
| Irradiation parameters: measurement of air Kerma (mGy) | At enrollment | Parameter given by the X-ray imaging device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time (min) | At enrollment | Total procedure time |
Countries
France
Contacts
Primary ContactFlorent Lalys, PhD
Outcome results
None listed