Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs

Completed

• Conditions: Cerebral Arteriovenous Malformations

• Registration Number: NCT02180958
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

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

Study Timeline

• Study First Submitted: 2014-04-25
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Device or procedure Adverse Events	1 month	Device or procedure related adverse events
Healing rate	12 or 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Describe funtional independence	1 and 12 months	Describe mRS scores assessed by a certified physician

Trial Locations

Locations (17)

CHRU Tours; 🇫🇷 Tours, France

CHP Clairval; 🇫🇷 Marseille, France

CHU Besançon; 🇫🇷 Besançon, France

CHI Dijon; 🇫🇷 Dijon, France

CHU Côte de Nacre; 🇫🇷 Caen, France

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Hôpital GUI DE CHAULLAC; 🇫🇷 Montpellier, France

Chu Pellegrin; 🇫🇷 Bordeaux, 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 Toulouse; 🇫🇷 Toulouse, France

HIA Sainte Anne; 🇫🇷 Toulon, France

CHU Strasbourg; 🇫🇷 Strasbourg, France