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

NCT ID: NCT02592733

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-04-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Historical Cohort

Patients who have undergone infrarenal endovascular repair at each centre in the past.

No interventions assigned to this group

Prospective Cohort

Patients undergoing infrarenal endovascular repair in the study using CYDAR in addition to the local angiography equipment.

CYDAR

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Tara Mastracci

Tara Mastracci, Clinical Lead, Aortic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara M Mastracci, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital NHS Foundation Trust

References

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.

Reference Type: DERIVED

PMID: 29804734 (View on PubMed)

Other Identifiers

IRAS171317

Identifier Type: -

Identifier Source: org_study_id