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

Therenva

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Procedure: Endovascular procedure

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT04709991

001

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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