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NCT04709991 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— COMPAR-MI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04709991
Other study ID # 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date July 1, 2021

Study information
Verified date October 2021
Source Therenva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France CH Libourne Libourne

Sponsors (2)
Lead Sponsor Collaborator
Therenva CH Libourne

Country where clinical trial is conducted

France, 

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