Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02180958

Acronym

cAVM

Enrollment

140

Registered

2014-07-03

Start date

2014-07-31

Completion date

2021-10-31

Last updated

2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Arteriovenous Malformations

Keywords

cerebral arteriovenous malformations, cAVM, ONYX

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results