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

Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization Clinical Trial

— CYDAR ILIAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03713450
• Other study ID #: RC18_0092
• Status: Terminated
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: February 7, 2020

Study information

• Verified date: May 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	Nantes University Hospital, Vascular surgery, Institut du Thorax	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose area product	Dose area product (DAP) by the end of the procedure.	The end of the procedure
Secondary	Number of DSA runs	Number of DSA runs by the end of the procedure.	The end of the procedure
Secondary	Air Kerma	Air Kerma (mGy) by the end of the procedure.	The end of the procedure
Secondary	Fluoroscopy time	Fluoroscopy time (min) by the end of the procedure.	The end of the procedure
Secondary	Contrast volume	Contrast volume (ml) by the end of the procedure.	The end of the procedure
Secondary	Operative time	Operative time (min) by the end of the procedure.	The end of the procedure
Secondary	Operator exposure	Operator exposure (Sv) by the end of the procedure.	The end of the procedure