Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs

NCT ID: NCT02180958

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2021-10-31

Brief Summary

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To assess safety and efficacy of ONYX treatment for cAVM:

Detailed Description

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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

Conditions

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Cerebral Arteriovenous Malformations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cerebral Arteriovenous Malformations

Adult patients requiring endovascular treatment of Cerebral Arteriovenous Malformations.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Ricolfi, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Dijon

Christophe Cognard, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Laurent Spelle, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bicêtre

Locations

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CHU Besançon

Besançon, , France

Site Status

Chu Pellegrin

Bordeaux, , France

Site Status

CHU Côte de Nacre

Caen, , France

Site Status

CHU Gabriel Montpied

Clermont-Ferrand, , France

Site Status

CHI Dijon

Dijon, , France

Site Status

CHP Clairval

Marseille, , France

Site Status

Hôpital GUI DE CHAULLAC

Montpellier, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

Fondation Ophtamoligique Rothschild

Paris, , France

Site Status

Groupe Hospitalier Pitier Salpetrière

Paris, , France

Site Status

Hôpital Beaujon

Paris, , France

Site Status

Hôpital Bicêtre

Paris, , France

Site Status

CHU Pontchaillou

Rennes, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

HIA Sainte Anne

Toulon, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CHRU Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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NV-ONY-002

Identifier Type: -

Identifier Source: org_study_id

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