Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization
Conditions
Keywords
Radiation, Contrast, Endovascular, Fusion imaging guidance, Iliac
Brief summary
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.
Interventions
DEVICEControl with imaging guidance
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).
DEVICEControl without imaging guidance
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).
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 or older, * Patients scheduled for aorto iliac endovascular revascularisation, * Pre-operative CT scan.
Exclusion criteria
* Women of childbearing age, * Absence of preoperative CT scan, * Emergency procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose area product | The end of the procedure | Dose area product (DAP) by the end of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Air Kerma | The end of the procedure | Air Kerma (mGy) by the end of the procedure. |
| Fluoroscopy time | The end of the procedure | Fluoroscopy time (min) by the end of the procedure. |
| Number of DSA runs | The end of the procedure | Number of DSA runs by the end of the procedure. |
| Operative time | The end of the procedure | Operative time (min) by the end of the procedure. |
| Operator exposure | The end of the procedure | Operator exposure (Sv) by the end of the procedure. |
| Contrast volume | The end of the procedure | Contrast volume (ml) by the end of the procedure. |
Countries
France
Outcome results
None listed