NCT03676868

Brief Summary

The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation. The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke. The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Nov 2018Nov 2028

First Submitted

Initial submission to the registry

September 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2028

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

September 11, 2018

Last Update Submit

June 19, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic

    associaton between dosage of endothelial marker in blood samples and correlation with clinical outcome

    6 months

  • Associaton between dosage of platelet and the arteriovenous malformation pronostic

    Dosage of platelet in blood samples and correlation with clinical outcome

    6 months

  • Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic

    Dosage of neutrophilic in blood samples and correlation with clinical outcome

    6 months

  • Associaton between neo-angiogenesis activation markers and the arteriovenous malformation pronostic

    Dosage neo-angiogenesis activation markers in blood samples and correlation with clinical outcome

    6 months

Eligibility Criteria

Age0 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with a cerebral arterioveinus malformation for which an intervention (endovascular treatment or surgery) or only clinical monitoring is planned

You may qualify if:

  • Patient over 18 years old
  • Patient with a cerebral AVM for which an intervention (endovascular treatment or surgery) or only clinical monitoring
  • Express consent to participate in the study
  • And
  • children
  • Free informed and express consent of both holders of the minor patient's parental authority, or, by way of derogation and only if the other holder of parental authority cannot give his or her consent within a time limit compatible with the methodological requirements specific to the conduct of the research with regard to its purposes, of one of the two holders of parental authority

You may not qualify if:

  • Patient benefiting from a legal protection measure
  • Pregnant or breast feeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Rotschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriovenous MalformationsRupture

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesIntracranial Arterial DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Central Study Contacts

Amélie Yavchitz

CONTACT

Jean Philippe DESILLES

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 19, 2018

Study Start

November 20, 2018

Primary Completion (Estimated)

November 19, 2028

Study Completion (Estimated)

November 19, 2028

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations