Arteriovenous FistuladAVFNCT02180945

ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae

An observational study of Arteriovenous Fistula, run by Medtronic Neurovascular Clinical Affairs at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Arteriovenous Fistula
How many people: 110 participants
Where: 1 siteFrance
Study dates: Jul 2013to May 2016
How long will I take part?: 12 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older 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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Covidien
Paris

Other trials in France

About this study

Official title: 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

Conditions: Arteriovenous Fistula
Keywords: dAVF, Arteriovenous fistula, ONYX
Medical subject headings: Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02180945
Study group	Role	What they receive
Intracranial Dural Arteriovenous Fistula		Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013May 2016

First posted3 Jul 2014 (estimated)
Study startJul 2013
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 110 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT02180945
Sponsor's protocol ID: NV-ONY-001
Acronym: dAVF
Status last verified: Jan 2019
First submitted: 25 Apr 2014
Last updated: 28 Jan 2019
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arteriovenous Fistula trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study
ClinicalTrials.gov ID: NCT02180945
Acronym / sponsor ID: dAVF / NV-ONY-001
Conditions: Arteriovenous Fistula
Keywords: dAVF, Arteriovenous fistula, ONYX
Study type: Observational
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
Study start: Jul 2013 (actual)
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 3 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
Intracranial Dural Arteriovenous Fistula	–	–Adult patients requiring endovascular treatment of Intracranial Dural Arteriovenous Fistulae.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older 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.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

4 secondary outcomes

Adverse event
Time frame: 3-6 months after procedure
Quality of life EQ-5D
Time frame: pre-procedure and at 3-6 months
Describe functional independence
Time frame: 1 and 12 months after procedure
Technical performance of the product
Time frame: 12 months after procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.

Related trials for Arteriovenous Fistula

Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
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Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christophe Cognard, Prof. Dr. principal investigator

University Hospital, Toulouse

Frédéric Ricolfi, Prof. Dr. principal investigator

Centre Hospitalier Universitaire Dijon

Patrick Courthéoux, Prof. Dr. principal investigator

University Hospital, Caen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arteriovenous Fistula, run by Medtronic Neurovascular Clinical Affairs at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological clinical evolution (time frame: 1Month post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02180945.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.