Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Single Centre Randomized Interventional Controlled Trial Comparing Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls

Conditions
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Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization

Intervention / Treatment
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* Device: Control with imaging guidance
* Device: Control without imaging guidance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control with imaging guidance<br> | Device: Control with imaging guidance<br>* 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).<br>|
| Active Comparator: Control without imaging guidance<br> | Device: Control without imaging guidance<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose area product | Dose area product (DAP) by the end of the procedure. | The end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation, Contrast, Endovascular, Fusion imaging guidance, Iliac