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

Completed

• Conditions: Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Cerebrovascular Diseases; Arteriovenous Malformation

• Registration Number: NCT03269734
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Status Verified: 2017-12
• Study Start: 2018-12-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Fondation Opthalmologique A de Rothschild; 🇫🇷 Paris, France