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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
45
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).
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).
Nantes University Hospital, Vascular surgery, Institut du Thorax
Nantes, France
Dose area product
Dose area product (DAP) by the end of the procedure.
Time frame: The end of the procedure
Number of DSA runs
Number of DSA runs by the end of the procedure.
Time frame: The end of the procedure
Air Kerma
Air Kerma (mGy) by the end of the procedure.
Time frame: The end of the procedure
Fluoroscopy time
Fluoroscopy time (min) by the end of the procedure.
Time frame: The end of the procedure
Contrast volume
Contrast volume (ml) by the end of the procedure.
Time frame: The end of the procedure
Operative time
Operative time (min) by the end of the procedure.
Time frame: The end of the procedure
Operator exposure
Operator exposure (Sv) by the end of the procedure.
Time frame: The end of the procedure
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