NCT03713450

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Control 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).
DEVICE	Control 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).

Timeline

• Start date: 2019-01-10
• Primary completion: 2020-02-07
• Completion: 2020-02-07
• First posted: 2018-10-19
• Last updated: 2023-05-23

Locations

1 site across 1 country: France