Cerebral Arteriovenous MalformationsBioMAVNCT03676868
Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations
An observational study of Cerebral Arteriovenous Malformations and Ruptured or Unruptured Cerebral Arteriovenous Malformations, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Cerebral Arteriovenous Malformations, Ruptured or Unruptured Cerebral Arteriovenous Malformations
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2018to 19 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patient with a cerebral arterioveinus malformation for which an intervention (endovascular treatment or surgery) or only clinical monitoring is planned
Who may be able to join
- Patient over 18 years old
- Patient with a cerebral AVM for which an intervention (endovascular treatment or surgery) or only clinical monitoring
- Express consent to participate in the study
- And
- children
- Free informed and express consent of both holders of the minor patient's parental authority, or, by way of derogation and only if the other holder of parental authority cannot give his or her consent within a time limit compatible with the methodological requirements specific to the conduct of the research with regard to its purposes, of one of the two holders of parental authority
Who cannot join
- Patient benefiting from a legal protection measure
- Pregnant or breast feeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean Philippe DESILLES contact
France1 site, 1 recruiting
- Recruiting
Fondation Ophtalmologique Rotschild
Paris, 75019
Dr Jean-Philippe DESILLES, jpdesilles@for.paris
About this study
Official title: Biology of Cerebral Arteriovenous Malformations : Study of the Link Between Blood Biomarkers and the Haemorrhagic Prognosis of Cerebral Arteriovenous Malformations
The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.
The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.
The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.
- Conditions
- Cerebral Arteriovenous Malformations, Ruptured or Unruptured Cerebral Arteriovenous Malformations
- Medical subject headings
- Intracranial Arteriovenous Malformations, Rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic
associaton between dosage of endothelial marker in blood samples and correlation with clinical outcome
Measured: 6 months
Associaton between dosage of platelet and the arteriovenous malformation pronostic
Dosage of platelet in blood samples and correlation with clinical outcome
Measured: 6 months
Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic
Dosage of neutrophilic in blood samples and correlation with clinical outcome
Measured: 6 months
Associaton between neo-angiogenesis activation markers and the arteriovenous malformation pronostic
Dosage neo-angiogenesis activation markers in blood samples and correlation with clinical outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start20 Nov 2018
- Primary completion19 Nov 2028 (estimated)
- Study completion19 Nov 2028 (estimated)
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676868
- Sponsor's protocol ID
- JDS_2018_6
- Acronym
- BioMAV
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biology of Cerebral Arteriovenous Malformations : Study of the Link Between Blood Biomarkers and the Haemorrhagic Prognosis of Cerebral Arteriovenous Malformations
- ClinicalTrials.gov ID
- NCT03676868
- Acronym / sponsor ID
- BioMAV / JDS_2018_6
- Conditions
- Cerebral Arteriovenous Malformations, Ruptured or Unruptured Cerebral Arteriovenous Malformations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 19 Nov 2028 (estimated)
- Study completion
- 19 Nov 2028 (estimated)
- First posted
- 19 Sep 2018 (actual)
- 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 cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.
The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.
The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with a cerebral arterioveinus malformation for which an intervention (endovascular treatment or surgery) or only clinical monitoring is planned
Key inclusion criteria (6 listed)
- Patient over 18 years old
- Patient with a cerebral AVM for which an intervention (endovascular treatment or surgery) or only clinical monitoring
- Express consent to participate in the study
- And
- children
Key exclusion criteria (2 listed)
- Patient benefiting from a legal protection measure
- Pregnant or breast feeding woman
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
Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic
Time frame: 6 months
associaton between dosage of endothelial marker in blood samples and correlation with clinical outcome
Associaton between dosage of platelet and the arteriovenous malformation pronostic
Time frame: 6 months
Dosage of platelet in blood samples and correlation with clinical outcome
Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic
Time frame: 6 months
Dosage of neutrophilic in blood samples and correlation with clinical outcome
Associaton between neo-angiogenesis activation markers and the arteriovenous malformation pronostic
Time frame: 6 months
Dosage neo-angiogenesis activation markers in blood samples and correlation with clinical outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
Jean Philippe DESILLES contact
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 Cerebral Arteriovenous Malformations and Ruptured or Unruptured Cerebral Arteriovenous Malformations, run by Fondation Ophtalmologique Adolphe de Rothschild 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie Yavchitz (01 48 63 64 54 ext. +33, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic (time frame: 6 months). The study lists 4 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 25 Jun 2025.