Vein of Galen Aneurysm

NCT06595264 | Completed

• 1 other identifier: SRB2024207
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Foundations of the clinical research project:
2. 2.Objectives of the clinical research project:
3. 3.Methodology of the clinical research project:
4. 4.Design of the clinical research project:
5. 5.Participants:

Conditions

Vein of Galen Malformation

Keywords

vein of Galen aneurysm; neuroradiological embolization

Outcome Measures

Primary Outcomes (1)

• Neurological outcome

  Neurological outcome after each embolization therapy will be recorded (%): No neurological deficit, minor neurological deficit, major neurological deficit

  28 days

Secondary Outcomes (2)

• Cardiac failure

  28 days

• Inotropic support

  28 days

Study Arms (1)

Vein of Galen malformation

All patients treated at Erasme hospital for a vein of Galen malformation.

Procedure: embolization therapy

Interventions

embolization therapy PROCEDURE

Embolization in the neuroradiological department is the Golden Standard for the treatment of vein of Galen malformations.

Vein of Galen malformation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated at Erasme for a vein of Galen malformation up to august 2024

You may qualify if:

• \- All patients treated at Erasme for a vein of Galen malformation

You may not qualify if:

• \- Opposition of parents to the use of medical data

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

H.U.B - Hôpital Erasme

Brussels, 1070, Belgium

Location

Related Publications (3)

• Ashida Y, Miyahara H, Sawada H, Mitani Y, Maruyama K. Anesthetic management of a neonate with vein of Galen aneurysmal malformations and severe pulmonary hypertension. Paediatr Anaesth. 2005 Jun;15(6):525-8. doi: 10.1111/j.1460-9592.2005.01471.x.

  PMID: 15910357 BACKGROUND

• Sinha PK, Neema PK, Rathod RC. Anesthesia and intracranial arteriovenous malformation. Neurol India. 2004 Jun;52(2):163-70.

  PMID: 15269462 BACKGROUND

• Mortazavi MM, Griessenauer CJ, Foreman P, Bavarsad Shahripour R, Shoja MM, Rozzelle CJ, Tubbs RS, Fisher WS 3rd, Fukushima T. Vein of Galen aneurysmal malformations: critical analysis of the literature with proposal of a new classification system. J Neurosurg Pediatr. 2013 Sep;12(3):293-306. doi: 10.3171/2013.5.PEDS12587. Epub 2013 Jul 26.

  PMID: 23889354 BACKGROUND

MeSH Terms

Conditions

Vein of Galen Malformations; Vein of Galen aneurysm

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Intracranial Arteriovenous Malformations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Denis Schmartz, MD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 15, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)