ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

Arteriovenous Fistula Clinical Trial

— dAVF  

Official title:

ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180945
• Other study ID #: NV-ONY-001
• Status: Completed
• Start date: July 2013
• Est. completion date: May 2016

Study information

• Verified date: January 2019
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Locations

Country	Name	City	State
France	Covidien	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological clinical evolution	Improved, Stable, Worsened, death	1Month post procedure
Primary	Healing rate	Number of patients with No residual early venous return	3-6 months post procedure
Secondary	Adverse event	The number of adverse events (causing death or otherwise)	3-6 months after procedure
Secondary	Quality of life EQ-5D	Health State Score increase	pre-procedure and at 3-6 months
Secondary	Describe functional independence	Describe mRS scores assessed by a certified physician	1 and 12 months after procedure
Secondary	Technical performance of the product	Volume injected per embolization session	12 months after procedure