AneurysmANENDOVASCNCT02878967
Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain Aneurysm
An observational study of Aneurysm, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The time-frame and the follow-up elements after embolization of brain aneurysm are not standardized. Therefore, few reliable follow-up data are available for these patients. This study aims at collecting standardized long term data for these patients, in order to assess the occurence of aneurysm recanalization and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2015to 24 Nov 2040
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing curative embolization of a brain aneurysm
Who may be able to join
- curative embolization of a brain aneurysm
- age >18 years old
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Patrick Vachey, ADM, +33 1 48 03 64 33, pvachey@for.paris
Raphaël Blanc, MD
About this study
Official title: Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain
The time-frame and the follow-up elements after embolization of brain aneurysm are not standardized. Therefore, few reliable follow-up data are available for these patients.
This study aims at collecting standardized long term data for these patients, in order to assess the occurence of aneurysm recanalization and particularly those requiring another intervention on the aneurysm.
Read the detailed description
An intracranial aneurysm is a localised dilatation in the wall of an intracranial artery, creating a zone of fragility where the main risk is rupture (meningeal haemorrhage). Intracranial aneurysms are the 1st vascular pathology treated in the NRI department at the Rothschild Foundation (FOR). Since 2002, between 150 and 250 patients have been treated each year using the embolisation technique (filling the aneurysm sac with coils). Over the last thirteen years, this represents the largest cohort in France, with more than 2,000 patients selectively treated for one or more intracranial aneurysms, i.e. more than 2,500 aneurysms. Treatment consists of excluding the aneurysmal cavity from the bloodstream, usually by "plugging" it with platinum metal coils.
After treatment by embolisation of the aneurysm, recanalisation (recirculation of blood in the aneurysm, exposing the patient to a new risk of haemorrhage due to aneurysmal rupture) of the cavity may occur after a few months or years (approximately in 7% of cases). In addition, new aneurysms may develop during the patient's lifetime, often several years later.
Another type of aneurysm treatment is also possible: surgical treatment, which consists of clipping the neck of the aneurysm. Whichever type of treatment is used, patients are monitored according to a protocol for the first year following treatment, with visits at 6 months and 1 year: an MRI is performed 6 months after embolisation. An arteriogram was performed at one year, and a consultation was held for clinical evaluation. A retrospective assessment of follow-up data (study of 2009-2013 files) showed that the date of this consultation varied considerably and that the schedule of follow-up visits over the first 10 years was not standardised, which means that reliable follow-up data are not available for these patients. The occurrence of recanalisation led us to propose standardised longer-term follow-up, with imaging (MRI and/or arteriography) 3 years after the operation. In our clinical experience, this follow-up schedule (at 3-6 months, 1 year and then 3 years) makes it possible to detect recanalisation requiring re-treatment. The aim of this research is to obtain standardised, longer-term follow-up data for a large series of patients who have undergone embolisation or surgical treatment of an intracranial aneurysm.
- Conditions
- Aneurysm
- Medical subject headings
- Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
long term evaluation of aneurysm occlusion
Roy classification
Measured: 5 years after embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start25 Nov 2015
- Primary completion24 Nov 2030 (estimated)
- Study completion24 Nov 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Raphaël Blanc, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878967
- Sponsor's protocol ID
- RBC_2015_14
- Acronym
- ANENDOVASC
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2016
- Last updated
- 22 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain
- ClinicalTrials.gov ID
- NCT02878967
- Acronym / sponsor ID
- ANENDOVASC / RBC_2015_14
- Conditions
- Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 24 Nov 2030 (estimated)
- Study completion
- 24 Nov 2040 (estimated)
- First posted
- 25 Aug 2016 (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 time-frame and the follow-up elements after embolization of brain aneurysm are not standardized. Therefore, few reliable follow-up data are available for these patients.
This study aims at collecting standardized long term data for these patients, in order to assess the occurence of aneurysm recanalization and particularly those requiring another intervention on the aneurysm.
Detailed description
An intracranial aneurysm is a localised dilatation in the wall of an intracranial artery, creating a zone of fragility where the main risk is rupture (meningeal haemorrhage). Intracranial aneurysms are the 1st vascular pathology treated in the NRI department at the Rothschild Foundation (FOR). Since 2002, between 150 and 250 patients have been treated each year using the embolisation technique (filling the aneurysm sac with coils). Over the last thirteen years, this represents the largest cohort in France, with more than 2,000 patients selectively treated for one or more intracranial aneurysms, i.e. more than 2,500 aneurysms. Treatment consists of excluding the aneurysmal cavity from the bloodstream, usually by "plugging" it with platinum metal coils.
After treatment by embolisation of the aneurysm, recanalisation (recirculation of blood in the aneurysm, exposing the patient to a new risk of haemorrhage due to aneurysmal rupture) of the cavity may occur after a few months or years (approximately in 7% of cases). In addition, new aneurysms may develop during the patient's lifetime, often several years later.
Another type of aneurysm treatment is also possible: surgical treatment, which consists of clipping the neck of the aneurysm. Whichever type of treatment is used, patients are monitored according to a protocol for the first year following treatment, with visits at 6 months and 1 year: an MRI is performed 6 months after embolisation. An arteriogram was performed at one year, and a consultation was held for clinical evaluation. A retrospective assessment of follow-up data (study of 2009-2013 files) showed that the date of this consultation varied considerably and that the schedule of follow-up visits over the first 10 years was not standardised, which means that reliable follow-up data are not available for these patients. The occurrence of recanalisation led us to propose standardised longer-term follow-up, with imaging (MRI and/or arteriography) 3 years after the operation. In our clinical experience, this follow-up schedule (at 3-6 months, 1 year and then 3 years) makes it possible to detect recanalisation requiring re-treatment. The aim of this research is to obtain standardised, longer-term follow-up data for a large series of patients who have undergone embolisation or surgical treatment of an intracranial aneurysm.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing curative embolization of a brain aneurysm
Key inclusion criteria (2 listed)
- curative embolization of a brain aneurysm
- age >18 years old
Key exclusion criteria (1 listed)
- none
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
long term evaluation of aneurysm occlusion
Time frame: 5 years after embolization
Roy classification
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 22 Jan 2026.
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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.
Raphaël Blanc, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
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 Aneurysm, 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 2 inclusion and 1 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 22 Jan 2026. 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 Raphaël Blanc, MD (+33 1 48 03 68 28, rblanc@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long term evaluation of aneurysm occlusion (time frame: 5 years after embolization). 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 22 Jan 2026.