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

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

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 Overview

• Status: Terminated
• Conditions: Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization
• Intervention / Treatment: Device: Control with imaging guidance; Device: Control without imaging guidance

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital, Vascular surgery, Institut du Thorax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control with imaging guidance	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).
Active Comparator: Control without imaging guidance	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Radiation; Endovascular; Contrast; Iliac; Fusion imaging guidance
• Other Study ID Numbers: RC18_0092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No