Not provided
Not provided
Not provided
Not provided
Premature termination of the research following an internal reorganization of the team no longer allowing the necessary resources to continue the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.
One way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.
This advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.
This trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control with imaging guidance | Experimental |
| |
| Control without imaging guidance | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control with imaging guidance | Device | Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles. The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile). |
| Measure | Description | Time Frame |
|---|---|---|
| Dose area product | Dose area product (DAP) by the end of the procedure. | The end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of DSA runs | Number of DSA runs by the end of the procedure. | The end of the procedure |
| Air Kerma | Air Kerma (mGy) by the end of the procedure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital, Vascular surgery, Institut du Thorax | Nantes | 44093 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control without imaging guidance | Device | Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles. The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile). |
|
| The end of the procedure |
| Fluoroscopy time | Fluoroscopy time (min) by the end of the procedure. | The end of the procedure |
| Contrast volume | Contrast volume (ml) by the end of the procedure. | The end of the procedure |
| Operative time | Operative time (min) by the end of the procedure. | The end of the procedure |
| Operator exposure | Operator exposure (Sv) by the end of the procedure. | The end of the procedure |