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| Name | Class |
|---|---|
| CH Libourne | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedures with EndoNaut |
| ||
| Procedures without Endonaut |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular procedure | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Patients requiring conventional surgical revascularization.
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Patients with chronic occlusive arthritis of the Lower Limbs with lesions on the femoro-popliteal stage and candidates for endovascular treatment of these lesions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Libourne | Libourne | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34509588 | Derived | Caradu C, Stenson K, Houmaida 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. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |