Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-08 @ 3:21 AM
Study NCT ID:
NCT03269734
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Study Overview
Official Title:
Evaluation of the Accuracy of the Vessel Navigator (Philips Healthcare) Tool for Catheterization of Aortic Arch and Supra-aortic Vessels - ARCHIBALD
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCHIBALD
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: