Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs
cAVM
1 other identifier
observational
140
1 country
17
Brief Summary
To assess safety and efficacy of ONYX treatment for cAVM:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2014
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedJanuary 31, 2022
January 1, 2022
7.3 years
April 25, 2014
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Device or procedure Adverse Events
Device or procedure related adverse events
1 month
Healing rate
No residual early venous return * 12 months after last embolization in case of complete treatment or stopping treatment; * 12 months after additional intervention in case of additional treatment required by neuro-surgery; * 36 months after additional intervention in case of additional treatment required by radio-surgery.
12 or 36 months
Secondary Outcomes (1)
Describe funtional independence
1 and 12 months
Study Arms (1)
Cerebral Arteriovenous Malformations
Adult patients requiring endovascular treatment of Cerebral Arteriovenous Malformations.
Eligibility Criteria
All the patients from participating centres for whom a cerebral AVM (not already treated) has to be treated (whatever treatment method anticipated) and who do not object to the collection and transmission of data concerning them, will be included in the so-called "screened" population.
You may qualify if:
- The patient presents a cerebral AVM (not already treated) that can be treated by embolization with Onyx whether or not associated with a cyanoacrylate based adhesive,
- The patient is at least 6 years old.
You may not qualify if:
- During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug.
- Any condition that could prevent follow-up of the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CHU Besançon
Besançon, France
Chu Pellegrin
Bordeaux, France
CHU Côte de Nacre
Caen, France
CHU Gabriel Montpied
Clermont-Ferrand, France
CHI Dijon
Dijon, France
CHP Clairval
Marseille, France
Hôpital GUI DE CHAULLAC
Montpellier, France
CHU Nantes
Nantes, France
Fondation Ophtamoligique Rothschild
Paris, France
Groupe Hospitalier Pitier Salpetrière
Paris, France
Hôpital Beaujon
Paris, France
Hôpital Bicêtre
Paris, France
CHU Pontchaillou
Rennes, France
CHU Strasbourg
Strasbourg, France
HIA Sainte Anne
Toulon, France
CHU Toulouse
Toulouse, France
CHRU Tours
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric Ricolfi, Prof. Dr.
Centre Hospitalier Universitaire Dijon
- PRINCIPAL INVESTIGATOR
Christophe Cognard, Prof. Dr.
University Hospital, Toulouse
- PRINCIPAL INVESTIGATOR
Laurent Spelle, Prof. Dr.
Hôpital Bicêtre
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2014
First Posted
July 3, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
January 31, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
No individual participant data will be available