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CompletedNCT01942512ARETAUpdated May 10, 2019

Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.

An observational study in Intracranial Aneurysm, sponsored by CHU de Reims. Completed at 22 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by CHU de Reims · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,275
Ages
18 Years and older
Sex
All
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Study summary

Endovascular treatment is now the first line treatment for the management of intracranial aneurysms. However aneurysm recanalization is an important limitation to this treatment. Several factors seems to be associated with aneurysm recanalization including medical history of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location, modalities of treatment, immediate post-operative occlusion of the aneurysm.

A precise knowledge of factors increasing the risk of aneurysm recanalization is quite important to optimize strategy of treatment and reduce the recanalization rate. No large, prospective, multicenter trial dealing with this question has been published in the literature.

Read the detailed description

The prevalence of intracranial aneurysms is high (between 2 and 3%). The major risk of an intracranial aneurysm is its rupture leading to intracranial bleeding (subarachnoid, parenchymal and/or intraventricular) associated with mortality and morbidity.

Endovascular treatment is now the first line treatment for both ruptured and unruptured aneurysms. One major limitation of this treatment is aneurysm recanalization observed in approximately 20% of aneurysms and leading to retreatment in approximately 10% of aneurysms.

CARAT trial has shown that the risk of rebleeding after aneurysm coiling is significantly associated with the quality of aneurysm occlusion. The risk of rebleeding is 1.1% in case of complete occlusion, 2.9% when aneurysm occlusion is between 91 and 99%, 5.9% when aneurysm occlusion is between 70 et 90%, and 17.6% when aneurysm occlusion is less than 70%. However it should be outlined that few studies have clearly analyzed the relation between recanalization and rebleeding.

Several factors are probably associated with aneurysm recanalization. Ruptured aneurysms are more prone to aneurysm recanalization than unruptured aneurysm. Age, elevated blood pressure, smoking probably play a role in aneurysm recanalization. Anatomical features are also probably key factors for aneurysm recanalization. Aneurysm and neck sizes are probably important factors for aneurysm recanalization. The role of aneurysm location is more controversial. Therapeutic factors certainly play also an important role, but precise analyses are still missing. The quality of post-operative aneurysm occlusion is probably important for the future evolution of the aneurysm. Surface-modified coils have not demonstrated any efficacy to prevent aneurysm recanalization. The role of adjunctive techniques has also not precisely be evaluated (remodeling, stenting).

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Conditions studied

  • Intracranial Aneurysm

Keywords

  • Intracranial Aneurysm - Endovascular treatment -
  • Coiling - Stenting - Flow diversion - Flow disruption -
  • Recanalization - Risk factors
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In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.

This study's enrollment of 1,275 is above the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 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

All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

Inclusion criteria

  • Patients treated by endovascular approach for intracranial aneurysm(s)
  • Patients older than 18 years
  • Patients accepting to participate to the study

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients protected by law
  • Patients already treated by endovascular approach for an intracranial aneurysm
  • Patients having a brain arteriovenous malformation
  • Patients having a fusiform aneurysm
  • Patients having a dissecting aneurysm
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,275 participants (actual)
Patient registry
No

Groups and cohorts

  • ARETA

    All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

    Device: Endovascular treatment of intracranial aneurysm

Interventions

  • DeviceEndovascular treatment of intracranial aneurysm
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What researchers measure

Primary outcomes

  1. aneurysm recanalization

    Time frame: assessed at 12 months

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Study locations

22 sites
  • Centre Hospitalier Universitaire de Besançon
    Besancon, 25030, France
  • CHU de Bordeaux
    Bordeaux, 33404, France
  • CHU de CAEN
    Caen, 14000, France
  • CHU de Clermont-Ferrand
    Clermont-ferrand, 63000, France
  • AP-HP, Hôpital Beaujon
    Clichy, 92110, France
  • AP-HP, Hôpital Henri Mondor
    Creteil, 94000, France
  • CHU de Dijon
    Dijon, 21079, France
  • CHRU de LILLE
    Lille, 59037, France
  • Hospices Civils de Lyon
    Lyon, 69002, France
  • CHU de MONTPELLIER
    Montpellier, 34295, France
  • CHU de Nancy
    Nancy, 54035, France
  • CHU de Nantes
    Nantes, 44093, France
  • CHU de Nice
    Nice, 06003, France
  • Centre Hospitalier Sainte-Anne
    Paris, 75014, France
  • AP-HP (Hôpital Pitié Salpétrière)
    Paris, France
  • Centre Hospitalier Universitaire de Poitiers
    Poitiers, 86021, France
  • Centre Hospitalier Universitaire de Reims
    Reims, 51092, France
  • CHU de Rennes
    Rennes, 35033, France
  • CHU de Saint-Etienne
    Saint-etienne, 42055, France
  • Hopital Foch
    Suresnes, 92151, France
  • CHU de Toulouse
    Toulouse, 31059, France
  • CHU de Tours
    Tours, 37044, France
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References and documents

Publications

  • Pierot L, Barbe C, Thierry A, Bala F, Eugene F, Cognard C, Herbreteau D, Velasco S, Chabert E, Desal H, Aggour M, Rodriguez-Regent C, Gallas S, Sedat J, Marnat G, Sourour N, Consoli A, Papagiannaki C, Spelle L, White P. Patient and aneurysm factors associated with aneurysm recanalization after coiling. J Neurointerv Surg. 2022 Nov;14(11):1096-1101. doi: 10.1136/neurintsurg-2021-017972. Epub 2021 Nov 5. PubMed 34740986 ↗
  • Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L; From the Departments of Neuroradiology, Research, and Public Health. Immediate post-operative aneurysm occlusion after endovascular treatment of intracranial aneurysms with coiling or balloon-assisted coiling in a prospective multicenter cohort of 1189 patients: Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2021 Oct;13(10):918-923. doi: 10.1136/neurintsurg-2020-017012. Epub 2020 Dec 21. PubMed 33443137 ↗
  • Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L. Delayed thromboembolic events after coiling of unruptured intracranial aneurysms in a prospective cohort of 335 patients. J Neurointerv Surg. 2021 Jun;13(6):534-540. doi: 10.1136/neurintsurg-2020-016654. Epub 2020 Sep 7. PubMed 32895321 ↗
  • Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L. Rebleeding and bleeding in the year following intracranial aneurysm coiling: analysis of a large prospective multicenter cohort of 1140 patients-Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2020 Dec;12(12):1219-1225. doi: 10.1136/neurintsurg-2020-015971. Epub 2020 Jun 16. PubMed 32546636 ↗
  • Pierot L, Barbe C, Ferre JC, Cognard C, Soize S, White P, Spelle L. Patient and aneurysm factors associated with aneurysm rupture in the population of the ARETA study. J Neuroradiol. 2020 Jun;47(4):292-300. doi: 10.1016/j.neurad.2019.07.007. Epub 2019 Sep 17. PubMed 31539582 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2019, 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
NCT01942512
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Sep 16, 2013
Start date
Nov 2013
Primary completion
Jun 23, 2017
Completion
Mar 2019
Last update
May 10, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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