Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs (cAVM)

Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study

To assess safety and efficacy of ONYX treatment for cAVM:

Study Overview

• Status: Completed
• Conditions: Cerebral Arteriovenous Malformations

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

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • CHU Besançon
  • Bordeaux, France
    • CHU Pellegrin
  • Caen, France
    • CHU côte de Nacre
  • Clermont-Ferrand, France
    • CHU Gabriel Montpied
  • Dijon, France
    • CHI Dijon
  • Marseille, France
    • CHP Clairval
  • Montpellier, France
    • Hôpital GUI DE CHAULLAC
  • Nantes, France
    • CHU Nantes
  • Paris, France
    • Hôpital Bicêtre
  • Paris, France
    • Hopital Beaujon
  • Paris, France
    • Fondation Ophtamoligique Rothschild
  • Paris, France
    • Groupe Hospitalier Pitier Salpetrière
  • Rennes, France
    • CHU Pontchaillou
  • Strasbourg, France
    • CHU Strasbourg
  • Toulon, France
    • HIA Sainte Anne
  • Toulouse, France
    • CHU Toulouse
  • Tours, France
    • CHRU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cerebral Arteriovenous Malformations; Adult patients requiring endovascular treatment of Cerebral Arteriovenous Malformations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe funtional independence	Describe mRS scores assessed by a certified physician	1 and 12 months

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Principal Investigator: Christophe Cognard, Prof. Dr., University Hospital, Toulouse; Principal Investigator: Frédéric Ricolfi, Prof. Dr., Centre Hospitalier Universitaire Dijon; Principal Investigator: Laurent Spelle, Prof. Dr., Hôpital Bicêtre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: ONYX; cerebral arteriovenous malformations; cAVM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Abnormalities; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: NV-ONY-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be available