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RecruitingNCT02878967ANENDOVASCUpdated Jan 22, 2026

Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain Aneurysm

An observational study in Aneurysm, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Started Nov 2015; still recruiting 10 years 11 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Aneurysm

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03

In context

Aneurysm

381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 157 across 132 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing curative embolization of a brain aneurysm

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • curative embolization of a brain aneurysm
  • age >18 years old

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. long term evaluation of aneurysm occlusion

    Roy classification

    Time frame: 5 years after embolization

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02878967
Responsible party
Sponsor
First posted
Aug 25, 2016
Start date
Nov 25, 2015
Primary completion
Nov 24, 2030 (estimated)
Completion
Nov 24, 2040 (estimated)
Last update
Jan 22, 2026

Study contacts

Raphaël Blanc, MD
Contact
rblanc@for.paris
+33 1 48 03 68 28
Amélie Yavchitz, MD
Contact
ayavchitz@for.paris
+33 1 48 03 64 54
Raphaël Blanc, MD
principal investigator · Fondation Ophtalmologique Adolphe de Rothschild
View the source record on ClinicalTrials.gov ↗

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