Skip to main content
OpenTrials
Completed

NCT Number: NCT03269734

Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD

This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms or arteriovenous malformations.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Catheterization of is performed for the diagnosis and treatment of cerebrovascular diseases. It is performed under X-ray scopy in frontal incidence with possible variations of the angulation of the arch to optimize the visualization of vessels 'origin (brachiocephalic trunk, left and right common carotid arteries, subclavian arteries).

Before the beginning of catheterization, a conventional arterial roadmap with iodine injection is usually performed. The Vessel Navigator (VN) developed by Philips allows the use of pre-acquired angio-scan or angio-MRI image by superimposing it (X-ray Fusion) on X-ray scopy to provide the arterial tracing (Fusion Roadmap).

An angio-MRI (Philips 3 Tesla MRI) imaging of the aortic arch will be first performed (as part of preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations). A first operator will perform the arteriography under the usual conditions without using the VN. A second operator will have access to the fusion imaging and will assess the accuracy of the coregistration. Snapshots will be taken by the second operator.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.

Exclusion criteria

  • Patients with contraindication to intravenous contrast.
  • Patients with catheterization of the supra-aortic vessels in an emergency settings (Stroke, acute bleeding)

Treatment and study plan

Primary outcomes

  1. Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.

    Time frame: baseline

    Measurement will be performed 1 cm above each ostium. There will be 4 measurements per patient (4 vessels analyzed).

Secondary outcomes

  1. Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

Evaluation of the Accuracy of the Vessel Navigator (Philips Healthcare) Tool for Catheterization of Aortic Arch and Supra-aortic Vessels - ARCHIBALD

Acronym: ARCHIBALD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2017
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.