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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Vascular Diseases Cerebrovascular Diseases Cardiovascular Diseases Aortic Aneurysm Arteriovenous Malformation

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 Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not). [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

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


Contacts
Contact: Laurence SALOMON 01.48.03.64.31 lsalomon@for.paris
Contact: Raphaël BLANC, MD rblanc@for.paris

Locations
France
Fondation Opthalmologique A de Rothschild Not yet recruiting
Paris, France, 75019
Contact: Raphaël BLANC       rblanc@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Raphaël BLANC, MD Fondation ophtalmologique de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03269734     History of Changes
Other Study ID Numbers: NI_RBC_2016_1
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Vascular Diseases
Cerebrovascular Diseases
Cardiovascular Diseases
Aortic aneurysm
Arteriovenous malformations
Catheterization

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Aneurysm
Aortic Aneurysm
Vascular Diseases
Hemangioma
Cerebrovascular Disorders
Aortic Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs