NCT02896881

Brief Summary

In previous studies exploring specific sequences of MRI (susceptibility weighted imaging (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging (static or dynamic). This prospective study aims to compare multisequence MRI to brain arteriography imaging in patients undergoing brain arteriovenous malformations embolization.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

8 years

First QC Date

September 7, 2016

Last Update Submit

January 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensitivity of multisequence MRI to detect a residual arteriovenous malformation after embolization

    Early opacification of a vein, possibly associated with the presence of abnormal vessels, will be sought, indicating a residual malformation. After interpretation of the MRI (angio-MRI with multi-sequences, magnetic susceptibility (SWI), arterial spin labelling (ASL) and static or dynamic angiography), the result will be coded dichotomously: (presence/absence of a residual malformation). The arteriography result will be coded in the same way. The sensitivity of the new MRI sequences for detecting a residual arteriovenous malformation after treatment by embolisation will thus be assessed, compared with arteriography (gold-standard).

    within 3 months after embolization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with brain Arteriovenous Malformations and embolization treatment scheduled.

You may qualify if:

  • Patient ≥ 18 years old
  • with brain Arteriovenous Malformations
  • embolization treatment scheduled

You may not qualify if:

  • patient's refusal to participate in the study
  • contraindication to undergo MRI examination
  • patient under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Opthalmologique A de Rothschild

Paris, 75019, France

Location

Study Officials

  • Raphaël BLANC, MD

    Fondation Ophtalmologique Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

February 1, 2017

Primary Completion

February 3, 2025

Study Completion

February 3, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations