A Case Control Observational Study to Assess CYDAR Automated Overlay

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02592733
Study type	Observational
Source	Royal Free Hospital NHS Foundation Trust
Contact
Status	Completed
Phase
Start date	November 2015
Completion date	April 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04149600` - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation	`NCT04035356` - HAART Annuloplasty Device Valve Repair Registry
Recruiting	`NCT02729064` - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose	Phase 1
Completed	`NCT02467062` - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.	N/A
Completed	`NCT02283307` - Dual Energy CT Urography With Reduced Iodinated Contrast	N/A
Completed	`NCT01678261` - X-chromosome Inactivation, Epigenetics and the Transcriptome	N/A
Terminated	`NCT01055275` - Cook Iliac Branch Graft Post-market Registry	N/A
Completed	`NCT00615888` - Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair	N/A
Completed	`NCT03510793` - Microcirculation and Anesthesia in Vascular Surgery
Completed	`NCT03207568` - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)	N/A
Recruiting	`NCT05073991` - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Completed	`NCT02000544` - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit	N/A
Not yet recruiting	`NCT01918982` - Circulating Endothelial Progenitor Cells and Aortic Aneurysm	N/A
Not yet recruiting	`NCT01918969` - Reference Values of Circulating Endothelial Progenitor Cells	N/A
Completed	`NCT01256372` - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery	Phase 2
Recruiting	`NCT00661518` - PET/CT Imaging of Aneurysm Wall Inflammation	N/A
Completed	`NCT00094575` - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)	Phase 4
Recruiting	`NCT04471909` - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness	N/A
Recruiting	`NCT05603520` - Phenotyping Heterogeneity and Regionality of the Aorta
Completed	`NCT03727542` - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms