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Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities (Explor-AVD)

Primary Purpose

Developmental Venous Anomaly

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Developmental Venous Anomaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

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

Exclusion Criteria:

  • Presenting a contraindication to the realization of hyperselective cathterism

Sites / Locations

  • Hôpital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood sample

Arm Description

Blood sampling Under general anesthesia

Outcomes

Primary Outcome Measures

Assessment of angiogenic and inflammatory growth factors
The 1st factor studied is VEGF-A
Assessment of angiogenic and inflammatory growth factors
The 2nd factor studied is VEGF-A
Assessment of angiogenic and inflammatory growth factors
The 3rd factor studied is angiopoitin-2
Assessment of angiogenic and inflammatory growth factors
The 4th factor studied is PDGF
Assessment of angiogenic and inflammatory growth factors
The 5th factor studied is angiopoietin-like 4

Secondary Outcome Measures

Full Information

First Posted
June 13, 2019
Last Updated
August 2, 2022
Sponsor
Hopital Foch
Collaborators
Collège de France
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1. Study Identification

Unique Protocol Identification Number
NCT03986853
Brief Title
Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
Acronym
Explor-AVD
Official Title
Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Patient with rare disease
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
Collaborators
Collège de France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Venous Anomaly

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood sample
Arm Type
Experimental
Arm Description
Blood sampling Under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling under general anesthesia
Primary Outcome Measure Information:
Title
Assessment of angiogenic and inflammatory growth factors
Description
The 1st factor studied is VEGF-A
Time Frame
1 day
Title
Assessment of angiogenic and inflammatory growth factors
Description
The 2nd factor studied is VEGF-A
Time Frame
1 day
Title
Assessment of angiogenic and inflammatory growth factors
Description
The 3rd factor studied is angiopoitin-2
Time Frame
1 day
Title
Assessment of angiogenic and inflammatory growth factors
Description
The 4th factor studied is PDGF
Time Frame
1 day
Title
Assessment of angiogenic and inflammatory growth factors
Description
The 5th factor studied is angiopoietin-like 4
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Presenting a DVA requiring hyperselective catheterization Having sign an informed consent form Exclusion Criteria: Presenting a contraindication to the realization of hyperselective cathterism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Rodesch
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
Country
France

12. IPD Sharing Statement

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Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities

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