Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs

Cerebral Arteriovenous Malformations Clinical Trial

— cAVM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180958
• Other study ID #: NV-ONY-002
• Status: Completed
• Start date: July 2014
• Est. completion date: October 2021

Study information

• Verified date: January 2022
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To assess safety and efficacy of ONYX treatment for cAVM:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Cerebral Arteriovenous Malformations
• Congenital Abnormalities
• Intracranial Arteriovenous Malformations

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Device or procedure Adverse Events	Device or procedure related adverse events	1 month
Primary	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	Describe funtional independence	Describe mRS scores assessed by a certified physician	1 and 12 months