Interest of New MRI Sequences After Embolization of Brain... | NCT02896881

Studies
Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations

NCT02896881

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Last Update Posted

Jan 22, 2026Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Brain Arteriovenous Malformations

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study no longer recruits patients, and its scientific relevance to healthcare practice has become obsolete.

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Feb 3, 2025Actual

Completion Date

Feb 3, 2025Actual

First Submitted Date

Sep 7, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Cerebral arteriovenous malformations are treated to eliminate the potential risk of haemorrhage. There are three possible treatment modalities: surgery, radiosurgery or embolisation. Complete exclusion of the arteriovenous malformation is a prerequisite for confirming that there is no residual risk of haemorrhage. After treatment, arteriography is the gold standard for confirming this exclusion. The absence of early opacification of the venous drainage is considered a sign of cure.

Several arteriographic aspects are possible after treatment by embolisation:

Arteriography may be strictly normal (no abnormalities).
The persistence of early venous opacification (presence of arterialised blood) indicates the persistence of a residual AVM.
Other vascular anomalies without early venous drainage may be present: dysplastic vessels (irregular shape, "corkscrew" appearance) ; capillary blush in the embolisation bed (hyperaemia) ; other: slow flow, slow filling, or widening of afferent arteries.

Our previous studies exploring the use of specific MRI sequences, in magnetic susceptibility (SWI), arterial spin labelling (ASL) and angiography (static or dynamic) sequences, have enabled us to demonstrate the very high sensitivity of these sequences for detecting an arteriovenous shunt, whether native (when the AVM is discovered) or residual after treatment. We would like to carry out a prospective study to compare cerebral arteriography and MRI (multi-sequence) in patients treated by embolisation for cerebral arteriovenous malformation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with brain Arteriovenous Malformations and embolization treatment scheduled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raphaël BLANC, MD	Fondation Ophtalmologique Adolphe de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Opthalmologique A de Rothschild		Paris		75019	France