ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Arteriovenous Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intracranial Dural Arteriovenous Fistula

Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No