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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03269734

Acronym

ARCHIBALD

Enrollment

Registered

2017-09-01

Start date

2018-12-01

Completion date

2018-12-01

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Arteriovenous Malformation, Cardiovascular Diseases, Cerebrovascular Diseases, Vascular Diseases

Keywords

Vascular Diseases, Cerebrovascular Diseases, Cardiovascular Diseases, Aortic aneurysm, Arteriovenous malformations, Catheterization

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.	baseline	Measurement will be performed 1 cm above each ostium. There will be 4 measurements per patient (4 vessels analyzed).

Secondary

Measure	Time frame
Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).	baseline

Countries

France

Outcome results