- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03986853
Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities (Explor-AVD)
August 2, 2022 updated by: Hopital Foch
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Suresnes, France
- Hopital Foch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Blood sample
Blood sampling Under general anesthesia
|
Blood sampling under general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of angiogenic and inflammatory growth factors
Time Frame: 1 day
|
The 1st factor studied is VEGF-A
|
1 day
|
|
Assessment of angiogenic and inflammatory growth factors
Time Frame: 1 day
|
The 2nd factor studied is VEGF-A
|
1 day
|
|
Assessment of angiogenic and inflammatory growth factors
Time Frame: 1 day
|
The 3rd factor studied is angiopoitin-2
|
1 day
|
|
Assessment of angiogenic and inflammatory growth factors
Time Frame: 1 day
|
The 4th factor studied is PDGF
|
1 day
|
|
Assessment of angiogenic and inflammatory growth factors
Time Frame: 1 day
|
The 5th factor studied is angiopoietin-like 4
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Georges Rodesch, Hopital Foch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 11, 2018
Primary Completion (ACTUAL)
January 11, 2021
Study Completion (ACTUAL)
January 11, 2021
Study Registration Dates
First Submitted
June 13, 2019
First Submitted That Met QC Criteria
June 13, 2019
First Posted (ACTUAL)
June 14, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017007-F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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