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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Endovascular procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Procedures with EndoNaut<br> | Procedure: Endovascular procedure<br>* 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.<br>|
| Procedures without Endonaut<br> | Procedure: Endovascular procedure<br>* 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.<br>|

What is the study measuring?
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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 |