Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation (COM-ENDO)

Therenva

Status: Unknown

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

Treatments: Procedure: Aorto-iliac endovascular procedure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04714268

002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Procedures with EndoNaut

Description:

Endovascular interventions using the EndoNaut workstation. 3D image fusion is used for overlaying arterial information on top of fluoroscopic images

Treatment:

Procedure: Aorto-iliac endovascular procedure

Procedures without EndoNaut

Description:

Control group, endovascular interventions without 3D image fusion

Treatment:

Procedure: Aorto-iliac endovascular procedure