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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

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE January 11, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 1st factor studied is VEGF-A
  • Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 2nd factor studied is VEGF-A
  • Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 3rd factor studied is angiopoitin-2
  • Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 4th factor studied is PDGF
  • Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
    The 5th factor studied is angiopoietin-like 4
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
Assessment of angiogenic and inflammatory growth factors [ Time Frame: 1 day ]
The angiogenic and inflammatory growth factors studied were VEGF-A, VEGF-C, angiopoitin-2, PDGF, and angiopoietin-like 4
Change History Complete list of historical versions of study NCT03986853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
Official Title  ICMJE Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Developmental Venous Anomaly
Intervention  ICMJE Procedure: Blood sampling
Blood sampling under general anesthesia
Study Arms  ICMJE Experimental: Blood sample
Blood sampling Under general anesthesia
Intervention: Procedure: Blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elisabeth Hulier-Ammar +33 1 46 25 11 75 drci-promotion@hopital-foch.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986853
Other Study ID Numbers  ICMJE 2017007-F
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hopital Foch
Study Sponsor  ICMJE Hopital Foch
Collaborators  ICMJE Collège de France
Investigators  ICMJE
Principal Investigator: Georges Rodesch Hôpital Foch
PRS Account Hopital Foch
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP