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

Aortic Aneurysm Clinical Trial

— COM-ENDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714268
• Other study ID #: 002
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2021
• Source: Therenva
• Contact: Florent Lalys, PhD
• Phone: +33789833846
• Email: florent.lalys[@]therenva.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Stenosis
• Constriction, Pathologic
• Iliac Aneurysm
• Iliac Artery Stenosis
• Stenoses, Aortic

Intervention

Procedure:
• Aorto-iliac endovascular procedure
Percutaneous procedure with stent placement

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (6)

Lead Sponsor	Collaborator
Therenva	Dijon University Hospital, Douai hospital, Polyclinique Bordeaux Nord Aquitaine, Rennes University Hospital, University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of contrast product used during the routine care procedure (ml)	Volume are reported in mL	At enrollment
Primary	Irradiation parameters: evaluation of the Fluoroscopy duration (min)	Parameter given by the X-ray imaging device	At enrollment
Primary	Irradiation parameters: dose-area quantification (mGy/m2)	Parameter given by the X-ray imaging device	At enrollment
Primary	Irradiation parameters: measurement of air Kerma (mGy)	Parameter given by the X-ray imaging device	At enrollment
Secondary	Procedure time (min)	Total procedure time	At enrollment