Clinical trial NCT03269734: Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD
Official title: Evaluation of the Accuracy of the Vessel Navigator (Philips Healthcare) Tool for Catheterization of Aortic Arch and Supra-aortic Vessels - ARCHIBALD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Cerebrovascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Arteriovenous Malformation
Keywords: Vascular Diseases
Cerebrovascular Diseases
Cardiovascular Diseases
Aortic aneurysm
Arteriovenous malformations
Catheterization
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-09-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.
timeFrame: baseline
Secondary outcomes:
measure: Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).
timeFrame: baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Opthalmologique A de Rothschild
Study officials:
affiliation: Fondation ophtalmologique de Rothschild
name: Raphaël BLANC, MD
role: PRINCIPAL_INVESTIGATOR
References: