- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02879071
Long Term Follow-up After Embolization of Brain Arteriovenous Malformations (MAV-endovasc)
July 6, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild
The time-frame and the follow-up elements after embolization of brain arteriovenous malformations are not standardized.
Therefore, few reliable follow-up data are available for these patients.
This study aims at collecting standardized long term data for these patients.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amélie Yavchitz, MD
- Phone Number: +33 1 48 03 64 54
- Email: ayachitz@for.paris
Study Locations
-
-
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Paris, France, 75019
- Recruiting
- Fondation Ophtalmologique Adolphe de Rothschild
-
Principal Investigator:
- Raphaël BLANC, MD
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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
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing embolization for an arteriovenous malformation
Description
Inclusion Criteria:
- arteriovenous malformation
- age > 18 years old
Exclusion Criteria:
- none
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
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
angiographic evaluation of the arteriovenous malformation occlusion
Time Frame: 5 years after embolization
|
5 years after embolization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baharvahdat H, Blanc R, Fahed R, Pooyan A, Mowla A, Escalard S, Delvoye F, Desilles JP, Redjem H, Ciccio G, Smajda S, Hamdani M, Mazighi M, Piotin M. Endovascular treatment as the main approach for Spetzler-Martin grade III brain arteriovenous malformations. J Neurointerv Surg. 2021 Mar;13(3):241-246. doi: 10.1136/neurintsurg-2020-016450. Epub 2020 Sep 28.
- Baharvahdat H, Blanc R, Fahed R, Smajda S, Ciccio G, Desilles JP, Redjem H, Escalard S, Mazighi M, Chauvet D, Robert T, Sasannejad P, Piotin M. Endovascular Treatment for Low-Grade (Spetzler-Martin I-II) Brain Arteriovenous Malformations. AJNR Am J Neuroradiol. 2019 Apr;40(4):668-672. doi: 10.3174/ajnr.A5988. Epub 2019 Feb 21.
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)
November 26, 2015
Primary Completion (Estimated)
November 25, 2023
Study Completion (Estimated)
November 25, 2033
Study Registration Dates
First Submitted
August 22, 2016
First Submitted That Met QC Criteria
August 22, 2016
First Posted (Estimated)
August 25, 2016
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 6, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBC_2015_17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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