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

January 25, 2019 updated by: Medtronic Neurovascular Clinical Affairs

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Covidien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients presenting at the participating centers for whom an intracranial dAVF (not previosly treated) needs to be treated (unrelated to the planned treatment) and who agree to the collection and transmission of related data.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intracranial Dural Arteriovenous Fistula
Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Investigators

  • Principal Investigator: Christophe Cognard, Prof. Dr., University Hospital, Toulouse
  • Principal Investigator: Frédéric Ricolfi, Prof. Dr., Centre Hospitalier Universitaire Dijon
  • Principal Investigator: Patrick Courthéoux, Prof. Dr., University Hospital, Caen
  • Principal Investigator: Laurent Spelle, Prof. Dr., Hopital Beaujon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV-ONY-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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