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

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ClinicalTrials.gov Identifier: NCT03986853
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Collège de France
Information provided by (Responsible Party):
Hopital Foch

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.

Condition or disease Intervention/treatment Phase
Developmental Venous Anomaly Procedure: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Blood sample
Blood sampling Under general anesthesia
Procedure: Blood sampling
Blood sampling under general anesthesia




Primary Outcome Measures :
  1. Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 1st factor studied is VEGF-A

  2. Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 2nd factor studied is VEGF-A

  3. Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 3rd factor studied is angiopoitin-2

  4. Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 4th factor studied is PDGF

  5. Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 5th factor studied is angiopoietin-like 4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986853


Contacts
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Contact: Elisabeth Hulier-Ammar +33 1 46 25 11 75 drci-promotion@hopital-foch.com

Locations
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France
Hôpital Foch Recruiting
Suresnes, France
Contact: Georges Rodesch         
Sponsors and Collaborators
Hopital Foch
Collège de France
Investigators
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Principal Investigator: Georges Rodesch Hôpital Foch

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03986853     History of Changes
Other Study ID Numbers: 2017007-F
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Central Nervous System Venous Angioma
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Vascular Malformations
Nervous System Malformations
Nervous System Diseases
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities