Clinical trial NCT04709991: Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
Official title: Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Therenva
Sponsor class: INDUSTRY
Collaborators: name: CH Libourne
First posted: 2021-01-14
Enrollment: 200
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: Patients with chronic occlusive arthritis of the Lower Limbs with lesions on the femoro-popliteal stage and candidates for endovascular treatment of these lesions.

Brief summary: To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to procedures performed without EndoNaut.

Detailed description: Peripheral artery disease (PAD) is characterized by a narrowing of the size of arteries, which resulting in a loss of hemodynamic load. Endovascular (or percutaneous) procedures performed at the infrainguinal level (axefemoro-popliteal) are very common in affected patients. Therenva offers a complete and consistent lightweight navigation solution (EndoNaut®) based on artificial intelligence (AI) algorithms, and providing technology accessible to all operating rooms for PAD procedures. The aim of this study is to demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to the procedures performed by EndoNaut.

Eligibility criteria: Inclusion Criteria:

* Patients with peripheral arterial disease of the lower limbs, all clinical stages, lesions of the femoro-popliteal stage and candidates for endovascular treatment of these lesions.
* 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: 1 day At enrollment
measure: Irradiation parameters: evaluation of the Fluoroscopy duration (min)
timeFrame: 1 day At enrollment
measure: Irradiation parameters: dose-area quantification (mGy/m2)
timeFrame: 1 day At enrollment
measure: Irradiation parameters: measurement of air Kerma (mGy)
timeFrame: 1 day At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Libourne
country: France
facility: CH Libourne
Study officials:
References:
citation: Caradu C, Stenson K, Houmaida H, Le Ny J, Lalys F, Ducasse E, Gheysens B. EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease. J Vasc Surg. 2022 Feb;75(2):651-659.e1. doi: 10.1016/j.jvs.2021.08.069. Epub 2021 Sep 10.