Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD (ARCHIBALD)
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|ClinicalTrials.gov Identifier: NCT03269734|
Recruitment Status : Not yet recruiting
First Posted : September 1, 2017
Last Update Posted : October 23, 2018
|Condition or disease|
|Vascular Diseases Cerebrovascular Diseases Cardiovascular Diseases Aortic Aneurysm Arteriovenous Malformation|
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.
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Evaluation of the Accuracy of the Vessel Navigator (Philips Healthcare) Tool for Catheterization of Aortic Arch and Supra-aortic Vessels - ARCHIBALD|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- 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).
- Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not). [ Time Frame: baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269734
|Contact: Laurence SALOMONemail@example.com|
|Contact: Raphaël BLANC, MDfirstname.lastname@example.org|
|Fondation Opthalmologique A de Rothschild||Not yet recruiting|
|Paris, France, 75019|
|Contact: Raphaël BLANC email@example.com|
|Principal Investigator:||Raphaël BLANC, MD||Fondation ophtalmologique de Rothschild|