Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm
- Sponsor
- Therenva
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Irradiation parameters: measurement of air Kerma (mGy)
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Irradiation parameters: measurement of air Kerma (mGy)
Time Frame: At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: dose-area quantification (mGy/m2)
Time Frame: At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
Time Frame: At enrollment
Parameter given by the X-ray imaging device
Volume of contrast product used during the routine care procedure (ml)
Time Frame: At enrollment
Volume are reported in mL
Secondary Outcomes
- Procedure time (min)(At enrollment)