CYDAR IMAGING GUIDANCE DURING EVAR
Research type
Research Study
Full title
A MULTICENTRE TRIAL COMPARING PATIENT SAFETY DURING INFRA RENAL AORTIC ANEURYSM REPAIR (EVAR) USING A NEW FULLY AUTOMATED AND ADAPTABLE CYDAR IMAGING GUIDANCE SOFTWARE TO HISTORICAL EXPERIENCE
IRAS ID
189718
Contact name
Tara M Mastracci
Contact email
Sponsor organisation
UCL
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 16 days
Research summary
An aortic abdominal aneurysm is defined as an abnormal dilatation of the aorta, prone to rupture, leading to a life-threatening condition.
Once AAA diagnosed, a CT-scan is required to assess the anatomy and if indicated an endovascular aneurysm repair (EVAR) is performed. This minimally invasive procedure allows the exclusion of the AAA by positioning an endograft inside the aorta through a femoral access under live X-ray (fluoroscopy) guidance.
X-rays are good at showing bones and radio-opaque endovascular tools, but they do not show soft tissues like the aorta, and they produce flat (2D) images that superimpose all the 3D anatomical features. In order to see the aorta, physicians have to inject iodinated contrast during high quality imaging recording. Consequently, the drawbacks of this minimally invasive procedure are the X-rays radiation exposure for both patients and medical staff, and the need of iodinated contrast injection, that does not contain any radioactive material but can lead to lifelong kidney problems. Reducing both in order to decrease their respective toxicities must be a priority for the endovascular surgeon.
Advanced imaging techniques allow overlay of a 3D vascular mask from a pre-operative CT scan onto the live X-ray image creating a ‘3D roadmap’ that helps guide surgery. It has been proven that using fusion during EVAR reduce both contrast and radiation dose. This advanced imaging application is currently available only in the latest expensive hybrid operating rooms.
This trial will examine the clinical benefits of the first advanced imaging application allowing automated 3D overlay guidance during EVAR in any theatre. The software, combined with secure and certified cloud high-performance computing, deduces the patient position from comparing the bony anatomy visible on the X-ray to that on the patient's CT scan, enabling it to produce and update accurate and reliable overlays.
Expected benefits include reducing the X-ray exposure and iodinated contrast use.REC name
North of Scotland Research Ethics Committee 1
REC reference
16/NS/0020
Date of REC Opinion
12 Feb 2016
REC opinion
Favourable Opinion