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

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm; Iliac Artery Stenosis; Iliac Aneurysm; Stenoses, Aortic
• Intervention / Treatment: Procedure: Aorto-iliac endovascular procedure

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Recruiting
    • Chu Rennes
    • Contact: Adrien Kaladji, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female patients with unilateral or bilateral common iliac aneurysm or stenosis, treated with endovascular technique

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Procedures with EndoNaut; 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; Percutaneous procedure with stent placement
Procedures without EndoNaut; Control group, endovascular interventions without 3D image fusion	Procedure: Aorto-iliac endovascular procedure; Percutaneous procedure with stent placement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Therenva
• Collaborators: Centre Hospitalier Universitaire Dijon; University Hospital, Brest; Rennes University Hospital; Polyclinique Bordeaux Nord Aquitaine; Douai hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Diseases; Aortic Valve Stenosis; Constriction, Pathologic; Aneurysm; Aortic Aneurysm; Iliac Aneurysm
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No