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

Not Applicable

Terminated

• Conditions: Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization
• Interventions: Device: Control with imaging guidance; Device: Control without imaging guidance

• Registration Number: NCT03713450
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2019-01-10
• Primary Completion: 2020-02-07
• Study Completion: 2020-02-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control with imaging guidance	Control with imaging guidance	-
Control without imaging guidance	Control without imaging guidance	-

Primary Outcome Measures

Name	Time	Method
Dose area product	The end of the procedure	Dose area product (DAP) by the end of the procedure.

Secondary Outcome Measures

Name	Time	Method
Number of DSA runs	The end of the procedure	Number of DSA runs by the end of the procedure.
Contrast volume	The end of the procedure	Contrast volume (ml) 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.
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.

Trial Locations

Locations (1)

Nantes University Hospital, Vascular surgery, Institut du Thorax; 🇫🇷 Nantes, France