Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation (COMPAR-MI)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Endovascular procedure

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Libourne, France
    • CH Libourne

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

Patients with chronic occlusive arthritis of the Lower Limbs with lesions on the femoro-popliteal stage and candidates for endovascular treatment of these lesions.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Procedures with EndoNaut	Procedure: Endovascular procedure; Creation of a bone and arterial panorama using EndoNaut® software. The routine care procedure begins with staged injections of contrast medium to provide a map of the lesions. The lesions are then treated by angioplasty with or without stenting.
Procedures without Endonaut	Procedure: Endovascular procedure; Creation of a bone and arterial panorama using EndoNaut® software. The routine care procedure begins with staged injections of contrast medium to provide a map of the lesions. The lesions are then treated by angioplasty with or without stenting.

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	1 day At enrollment
Irradiation parameters: evaluation of the Fluoroscopy duration (min)	Parameter given by the X-ray imaging device	1 day At enrollment
Irradiation parameters: dose-area quantification (mGy/m2)	Parameter given by the X-ray imaging device	1 day At enrollment
Irradiation parameters: measurement of air Kerma (mGy)	Parameter given by the X-ray imaging device	1 day At enrollment

Collaborators and Investigators

• Sponsor: Therenva
• Collaborators: CH Libourne

Publications and helpful links

General Publications

• Caradu C, Stenson K, Houmaïda 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

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
• product manufactured in and exported from the U.S.: No