NCT03986853

Brief Summary

The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 11, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

June 13, 2019

Last Update Submit

August 2, 2022

Conditions

Developmental Venous Anomaly

Outcome Measures

Primary Outcomes (5)

  • Assessment of angiogenic and inflammatory growth factors

    The 1st factor studied is VEGF-A

    1 day

  • Assessment of angiogenic and inflammatory growth factors

    The 2nd factor studied is VEGF-A

    1 day

  • Assessment of angiogenic and inflammatory growth factors

    The 3rd factor studied is angiopoitin-2

    1 day

  • Assessment of angiogenic and inflammatory growth factors

    The 4th factor studied is PDGF

    1 day

  • Assessment of angiogenic and inflammatory growth factors

    The 5th factor studied is angiopoietin-like 4

    1 day

Study Arms (1)

Blood sample

EXPERIMENTAL

Blood sampling Under general anesthesia

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

Blood sampling under general anesthesia

Blood sample

Eligibility Criteria

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

You may qualify if:

  • Presenting a DVA requiring hyperselective catheterization
  • Having sign an informed consent form

You may not qualify if:

  • Presenting a contraindication to the realization of hyperselective cathterism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, France

Location

MeSH Terms

Conditions

Central Nervous System Venous Angioma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsCentral Nervous System Vascular MalformationsNervous System MalformationsNervous System DiseasesVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Georges Rodesch

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 14, 2019

Study Start

January 11, 2018

Primary Completion

January 11, 2021

Study Completion

January 11, 2021

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

FR(1)