NCT02592733

A Case Control Observational Study to Assess CYDAR Automated Overlay Guidance During EVAR

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Royal Free Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational trial to determine if use of fusion imaging in infrarenal endovascular aneurysm repair will decrease the radiation dose and improve patient safety for this procedure.

Detailed description

The aorta is the main artery of the body. An aortic abdominal aneurysm (AAA) is defined as an abnormal dilatation of the aorta, based on a diameter of 3 cm or more, due to a weakness of the aortic wall that is prone to rupture, leading to a lifethreatening condition. Once AAA diagnosed, a CTscan is required to assess the anatomy and if indicate an endovascular aneurysm repair (EVAR) is performed. This mini invasive procedure allows the exclusion of the AAA by positioning an endograft inside the aorta through a femoral access under live Xrays (fluoroscopy) guidance. The Xrays are good at showing bones and radioopaque 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. One way to improve clinicians' perception of peroperative 3D vascular anatomy is to accurately overlay selected information from the preoperative CT scan (a 3D vascular mask) onto the live Xray image creating a '3D roadmap'. This advanced imaging application is currently available only in the latest expensive hybrid 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 Xray to that on the patient's CT scan, enabling it to produce and update accurate and reliable overlays of the diagnostic CT 3D vascular mask throughout the operation (www.cydar.co.uk). Expected benefits include reducing the total Xray exposure of the patients and staff, reduced use of iodinated contrast (a major cause of kidney failure) and shortening procedure duration.

Conditions

• Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	CYDAR	CYDAR is an automated image mask that is cloud based adn delivered to operating theatres over a secure network. It fuses preoperative images with intraoperative images to provide more accurate image guidance for the surgeon.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-03-01
• Completion: 2018-04-01
• First posted: 2015-10-30
• Last updated: 2018-04-11