Clinical trial NCT02180958: Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs
Official title: Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Arteriovenous Malformations
Keywords: cerebral arteriovenous malformations
cAVM
ONYX
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2014-07-03
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: To assess safety and efficacy of ONYX treatment for cAVM:

Detailed description: The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at:

* 12 months post last embolization in case of treatment with embolization only
* 12 months after additional treatment with neurosurgery
* 36 months after additional treatment with radiosurgery

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug.
* The patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. For patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented.
* Any condition that could prevent follow-up of the patient.

Primary outcomes:
measure: Incidence of Device or procedure Adverse Events
timeFrame: 1 month
measure: Healing rate
timeFrame: 12 or 36 months
Secondary outcomes:
measure: Describe funtional independence
timeFrame: 1 and 12 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: Chu Pellegrin
city: Caen
country: France
facility: CHU Côte de Nacre
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Dijon
country: France
facility: CHI Dijon
city: Marseille
country: France
facility: CHP Clairval
city: Montpellier
country: France
facility: Hôpital GUI DE CHAULLAC
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Fondation Ophtamoligique Rothschild
city: Paris
country: France
facility: Groupe Hospitalier Pitier Salpetrière
city: Paris
country: France
facility: Hôpital Beaujon
city: Paris
country: France
facility: Hôpital Bicêtre
city: Rennes
country: France
facility: CHU Pontchaillou
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulon
country: France
facility: HIA Sainte Anne
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Frédéric Ricolfi, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Toulouse
name: Christophe Cognard, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bicêtre
name: Laurent Spelle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: