Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Therenva
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Volume of contrast product used during the routine care procedure (ml)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Volume of contrast product used during the routine care procedure (ml)
Time Frame: 1 day At enrollment
Volume are reported in mL
Irradiation parameters: dose-area quantification (mGy/m2)
Time Frame: 1 day At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
Time Frame: 1 day At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: measurement of air Kerma (mGy)
Time Frame: 1 day At enrollment
Parameter given by the X-ray imaging device