ONYX Evaluation in the Endovascular Treatment of Intracra... | NCT02180945

Studies
ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

NCT02180945

Sponsor

Medtronic Neurovascular Clinical Affairs

Status

Completed

Last Update Posted

Jan 28, 2019Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Arteriovenous Fistula

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013Actual

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 25, 2014

First Submission Date that Met QC Criteria

Jul 1, 2014

First Posted Date

Jul 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2019

Last Update Posted Date

Jan 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intracranial Dural Arteriovenous Fistula		Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Adverse event	The number of adverse events (causing death or otherwise)	3-6 months after procedure
Quality of life EQ-5D	Health State Score increase

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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.	Hôpital Beaujon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covidien		Paris			France

Condition Browse Module

MeSH Terms

ID	Term
D001164	Arteriovenous Fistula

Ancestor Terms

ID	Term
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided