Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Endovascular procedure

• Registration Number: NCT04709991
• Lead Sponsor: Therenva

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Procedures with EndoNaut	Endovascular procedure	-
Procedures without Endonaut	Endovascular procedure	-

Primary Outcome Measures

Name	Time	Method
Volume of contrast product used during the routine care procedure (ml)	1 day At enrollment	Volume are reported in mL
Irradiation parameters: dose-area quantification (mGy/m2)	1 day At enrollment	Parameter given by the X-ray imaging device
Irradiation parameters: evaluation of the Fluoroscopy duration (min)	1 day At enrollment	Parameter given by the X-ray imaging device
Irradiation parameters: measurement of air Kerma (mGy)	1 day At enrollment	Parameter given by the X-ray imaging device

Trial Locations

Locations (1)

CH Libourne; 🇫🇷 Libourne, France