ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae (dAVF)

Medtronic

Status: Completed

Conditions: Arteriovenous Fistula

Study type: Observational

Funder types: Industry

Identifiers

NCT02180945

NV-ONY-001

Details and patient eligibility

About

The objective of this study is to evaluate the safety and performance post last embolization with Onyx

Enrollment: 110 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has an intracranial dAVF which could be treated by ONYX embolization, whether or not associated to other embolization products.
• The patient is at least 18 years of age.

Exclusion criteria

• The patient needs to be treated for the dAVF with another treatment option (for example by surgery) than embolization within a period of less than 6 months (to be counted as from the first treatment)
• The patient participates to another clinical study during the treatment period for his/her dAVF, evaluating another medical devices, procedure or medication.
• The patient refuses to give consent to the collection and processing of data required for centralized monitoring.
• A condition which could jeopardize follow-up of the patient.

Trial design

110 participants in 1 patient group

Intracranial Dural Arteriovenous Fistula

Description:

Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.