ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

Completed

• Conditions: Arteriovenous Fistula

• Registration Number: NCT02180945
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological clinical evolution	1Month post procedure	Improved, Stable, Worsened, death
Healing rate	3-6 months post procedure	Number of patients with No residual early venous return

Secondary Outcome Measures

Name	Time	Method
Adverse event	3-6 months after procedure	The number of adverse events (causing death or otherwise)
Quality of life EQ-5D	pre-procedure and at 3-6 months	Health State Score increase
Describe functional independence	1 and 12 months after procedure	Describe mRS scores assessed by a certified physician
Technical performance of the product	12 months after procedure	Volume injected per embolization session

Trial Locations

Locations (1)

Covidien; 🇫🇷 Paris, France