NCT03269734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 26, 2019

Status Verified

December 1, 2017

Enrollment Period

Same day

First QC Date

August 30, 2017

Last Update Submit

March 25, 2019

Conditions

Vascular DiseasesCerebrovascular DiseasesCardiovascular DiseasesAortic AneurysmArteriovenous Malformation

Keywords

Vascular DiseasesCerebrovascular DiseasesCardiovascular DiseasesAortic aneurysmArteriovenous malformationsCatheterization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Subjective opinion of the second operator on the aspect of registration to carry out the catheterization (satisfactory or not).

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.

You may not qualify if:

  • Patients with contraindication to intravenous contrast.
  • Patients with catheterization of the supra-aortic vessels in an emergency settings (Stroke, acute bleeding)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Opthalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Vascular DiseasesCerebrovascular DisordersCardiovascular DiseasesAortic AneurysmArteriovenous Malformations

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmAortic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Raphaël BLANC, MD

    Fondation ophtalmologique de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

December 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 26, 2019

Record last verified: 2017-12

Locations

FR(1)