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

NCT02592733 | Completed

• 1 other identifier: IRAS171317
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

CYDAR 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.

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Female participants who is pregnant or planning pregnancy during the course of the study.
• 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.
• Any patient requiring an associated procedure (iliac branch device implantation, renal or mesenteric angioplasty)
• Ruptured AAA and emergency procedures

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead

Related Publications (1)

• 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.

  PMID: 29804734 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Tara M Mastracci, MD

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tara Mastracci, Clinical Lead, Aortic Surgery

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 30, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04