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

Cardiovascular Diseases Clinical Trial

— ARCHIBALD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269734
• Other study ID #: NI_RBC_2016_1
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Arteriovenous Malformation
• Arteriovenous Malformations
• Cardiovascular Diseases
• Cerebrovascular Diseases
• Cerebrovascular Disorders
• Congenital Abnormalities
• Hemangioma
• Vascular Diseases

Locations

Country	Name	City	State
France	Fondation Opthalmologique A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Offset (in mm) between the lateral edge of the opacified artery and that visualized with the fusion imaging.	Measurement will be performed 1 cm above each ostium. There will be 4 measurements per patient (4 vessels analyzed).	baseline
Secondary	Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).		baseline