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

Medtronic

Status: Completed

Conditions: Cerebral Arteriovenous Malformations

Study type: Observational

Funder types: Industry

Identifiers

NCT02180958

NV-ONY-002

Details and patient eligibility

About

To assess safety and efficacy of ONYX treatment for cAVM:

Full 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

Enrollment: 140 patients

Sex: All

Ages: 6+ years old

Volunteers: No 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.

Trial design

140 participants in 1 patient group

Cerebral Arteriovenous Malformations

Description:

Adult patients requiring endovascular treatment of Cerebral Arteriovenous Malformations.