Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation

Conditions
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Aortic Aneurysm, Iliac Aneurysm, Stenoses, Aortic, Iliac Artery Stenosis

Intervention / Treatment
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* Procedure: Aorto-iliac endovascular procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Procedures with EndoNaut<br>Endovascular interventions using the EndoNaut workstation. 3D image fusion is used for overlaying arterial information on top of fluoroscopic images | Procedure: Aorto-iliac endovascular procedure<br>* Percutaneous procedure with stent placement<br>|
| Procedures without EndoNaut<br>Control group, endovascular interventions without 3D image fusion | Procedure: Aorto-iliac endovascular procedure<br>* Percutaneous procedure with stent placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of contrast product used during the routine care procedure (ml) | Volume are reported in mL | At enrollment | 
| Irradiation parameters: evaluation of the Fluoroscopy duration (min) | Parameter given by the X-ray imaging device | At enrollment | 
| Irradiation parameters: dose-area quantification (mGy/m2) | Parameter given by the X-ray imaging device | At enrollment | 
| Irradiation parameters: measurement of air Kerma (mGy) | Parameter given by the X-ray imaging device | At enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time (min) | Total procedure time | At enrollment |