Clinical trial NCT04714268: Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
Official title: Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Iliac Aneurysm
Stenoses, Aortic
Iliac Artery Stenosis
Lead sponsor: Therenva
Sponsor class: INDUSTRY
Collaborators: name: Rennes University Hospital
name: Douai hospital
name: Centre Hospitalier Universitaire Dijon
name: University Hospital, Brest
name: Polyclinique Bordeaux Nord Aquitaine
First posted: 2021-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with unilateral or bilateral common iliac aneurysm or stenosis, treated with endovascular technique

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Volume of contrast product used during the routine care procedure (ml)
timeFrame: At enrollment
measure: Irradiation parameters: evaluation of the Fluoroscopy duration (min)
timeFrame: At enrollment
measure: Irradiation parameters: dose-area quantification (mGy/m2)
timeFrame: At enrollment
measure: Irradiation parameters: measurement of air Kerma (mGy)
timeFrame: At enrollment
Secondary outcomes:
measure: Procedure time (min)
timeFrame: At enrollment
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References: