A Case Control Observational Study to Assess CYDAR Automated Overlay Guidance During EVAR (CYDAR-IRAAA)

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Device: CYDAR

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.

• Study Type: Observational
• Enrollment (Actual): 44

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

All patients deemed fit for infrarenal repair at one of 4 centres.

Description

Inclusion Criteria:

1. willing and able to give informed consent,and
2. aged 18 or older, and
3. been scheduled for endovascular repair of an infrarenal aortic aneurysm (EVAR), and
4. who have had a preoperative diagnostic CT scan, and
5. able (in the investigator's opinion) and willing to comply with the study requirements.

Exclusion Criteria:

1. Female participants who is pregnant or planning pregnancy during the course of the study.
2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
3. Any patient requiring an associated procedure (iliac branch device implantation, renal or mesenteric angioplasty)
4. Ruptured AAA and emergency procedures

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Historical Cohort; Patients who have undergone infrarenal endovascular repair at each centre in the past.
Prospective Cohort; Patients undergoing infrarenal endovascular repair in the study using CYDAR in addition to the local angiography equipment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dose (DAP)	The Dose Area Product acquired in surgery	This will be measured during the index operation. There will be no further radiation after that. Investigators expect that this study should take 12 months for full enrollment and analysis

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Tara M Mastracci, MD, Royal Free Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• Maurel B, Martin-Gonzalez T, Chong D, Irwin A, Guimbretiere G, Davis M, Mastracci TM. A prospective observational trial of fusion imaging in infrarenal aneurysms. J Vasc Surg. 2018 Dec;68(6):1706-1713.e1. doi: 10.1016/j.jvs.2018.04.015. Epub 2018 May 24.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: IRAS171317