Cerebral Arteriovenous MalformationscAVMNCT02180958
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs
An observational study of Cerebral Arteriovenous Malformations, run by Medtronic Neurovascular Clinical Affairs at 17 sites in France.
Trial summary
To assess safety and efficacy of ONYX treatment for cAVM: Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cerebral Arteriovenous Malformations
- How many people
- 140 participants
- Where
- 17 sitesFrance
- Study dates
- Jul 2014to Oct 2021
- How long will I take part?
- 36 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients from participating centres for whom a cerebral AVM (not already treated) has to be treated (whatever treatment method anticipated) and who do not object to the collection and transmission of data concerning them, will be included in the so-called "screened" population.
Who may be able to join
- The patient presents a cerebral AVM (not already treated) that can be treated by embolization with Onyx whether or not associated with a cyanoacrylate based adhesive,
- The patient is at least 6 years old.
Who cannot join
- During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug.
- The patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. For patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented.
- Any condition that could prevent follow-up of the patient.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU Besançon
Besançon
Chu Pellegrin
Bordeaux
CHU Côte de Nacre
Caen
CHU Gabriel Montpied
Clermont-Ferrand
CHI Dijon
Dijon
CHP Clairval
Marseille
Hôpital GUI DE CHAULLAC
Montpellier
CHU Nantes
Nantes
Fondation Ophtamoligique Rothschild
Paris
Groupe Hospitalier Pitier Salpetrière
Paris
Hôpital Beaujon
Paris
Hôpital Bicêtre
Paris
CHU Pontchaillou
Rennes
CHU Strasbourg
Strasbourg
HIA Sainte Anne
Toulon
CHU Toulouse
Toulouse
CHRU Tours
Tours
About this study
Official title: Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study
To assess safety and efficacy of ONYX treatment for cAVM:
Read the detailed description
The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at:
- 12 months post last embolization in case of treatment with embolization only
- 12 months after additional treatment with neurosurgery
- 36 months after additional treatment with radiosurgery
- Conditions
- Cerebral Arteriovenous Malformations
- Keywords
- cerebral arteriovenous malformations, cAVM, ONYX
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Arteriovenous Malformations | Adult patients requiring endovascular treatment of Cerebral Arteriovenous Malformations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device or procedure Adverse Events
Device or procedure related adverse events
Measured: 1 month
Healing rate
No residual early venous return
- 12 months after last embolization in case of complete treatment or stopping treatment;
- 12 months after additional intervention in case of additional treatment required by neuro-surgery;
- 36 months after additional intervention in case of additional treatment required by radio-surgery.
Measured: 12 or 36 months
Secondary outcomes (1)
Describe funtional independence
Describe mRS scores assessed by a certified physician
Measured: 1 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arteriovenous MalformationsStudies 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
- 140 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Ricolfi, Prof. Dr., Principal investigator, Centre Hospitalier Universitaire DijonChristophe Cognard, Prof. Dr., Principal investigator, University Hospital, ToulouseLaurent Spelle, Prof. Dr., Principal investigator, Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180958
- Sponsor's protocol ID
- NV-ONY-002
- Acronym
- cAVM
- Status last verified
- Jan 2022
- First submitted
- 25 Apr 2014
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual participant data will be available
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study
- ClinicalTrials.gov ID
- NCT02180958
- Acronym / sponsor ID
- cAVM / NV-ONY-002
- Conditions
- Cerebral Arteriovenous Malformations
- Keywords
- cerebral arteriovenous malformations, cAVM, ONYX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (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.
To assess safety and efficacy of ONYX treatment for cAVM:
Detailed description
The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at:
- 12 months post last embolization in case of treatment with embolization only
- 12 months after additional treatment with neurosurgery
- 36 months after additional treatment with radiosurgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Arteriovenous Malformations | – | –Adult patients requiring endovascular treatment of Cerebral Arteriovenous Malformations. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients from participating centres for whom a cerebral AVM (not already treated) has to be treated (whatever treatment method anticipated) and who do not object to the collection and transmission of data concerning them, will be included in the so-called "screened" population.
Key inclusion criteria (2 listed)
- The patient presents a cerebral AVM (not already treated) that can be treated by embolization with Onyx whether or not associated with a cyanoacrylate based adhesive,
- The patient is at least 6 years old.
Key exclusion criteria (3 listed)
- During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug.
- The patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. For patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented.
- Any condition that could prevent 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
Incidence of Device or procedure Adverse Events
Time frame: 1 month
Device or procedure related adverse events
Healing rate
Time frame: 12 or 36 months
No residual early venous return * 12 months after last embolization in case of complete treatment or stopping treatment; * 12 months after additional intervention in case of additional treatment required by neuro-surgery; * 36 months after additional intervention in case of additional treatment required by radio-surgery.
1 secondary outcome
Describe funtional independence
Time frame: 1 and 12 months
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 31 Jan 2022.
- Individual participant dataSharing planned: No. No individual participant data will be available
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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.
Frédéric Ricolfi, Prof. Dr. principal investigator
Centre Hospitalier Universitaire Dijon
Christophe Cognard, Prof. Dr. principal investigator
University Hospital, Toulouse
Laurent Spelle, Prof. Dr. principal investigator
Hôpital Bicêtre
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Arteriovenous Malformations, run by Medtronic Neurovascular Clinical Affairs at 17 sites 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 3 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 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
Incidence of Device or procedure Adverse Events (time frame: 1 month). 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?
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 31 Jan 2022.