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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Raphaël Blanc, MD contact

+33 1 48 03 68 28

rblanc@for.paris

Amélie Yavchitz, MD contact

+33 1 48 03 64 54

ayavchitz@for.paris

France1 site, 1 recruiting
  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris, 75019

    Patrick Vachey, ADM, +33 1 48 03 64 33, pvachey@for.paris

    Raphaël Blanc, MD

    Recruiting

Other trials in France

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.

  1. 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.

  1. First posted25 Aug 2016 (estimated)
  2. Study start25 Nov 2015
  3. Primary completion24 Nov 2030 (estimated)
  4. Study completion24 Nov 2040 (estimated)

Resources

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)
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

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.

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