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

• Conditions: Stenoses, Aortic; Aortic Aneurysm; Iliac Aneurysm; Iliac Artery Stenosis
• Interventions: Procedure: Aorto-iliac endovascular procedure

• Registration Number: NCT04714268
• Lead Sponsor: Therenva

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.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Procedures with EndoNaut	Aorto-iliac endovascular procedure	Endovascular interventions using the EndoNaut workstation. 3D image fusion is used for overlaying arterial information on top of fluoroscopic images
Procedures without EndoNaut	Aorto-iliac endovascular procedure	Control group, endovascular interventions without 3D image fusion

Primary Outcome Measures

Name	Time	Method
Irradiation parameters: measurement of air Kerma (mGy)	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: evaluation of the Fluoroscopy duration (min)	At enrollment	Parameter given by the X-ray imaging device
Volume of contrast product used during the routine care procedure (ml)	At enrollment	Volume are reported in mL

Secondary Outcome Measures

Name	Time	Method
Procedure time (min)	At enrollment	Total procedure time

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France