AzTrials
AzTrials

Intracranial AneurysmARETANCT01942512

Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.

An observational study of Intracranial Aneurysm, run by CHU de Reims at 22 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Endovascular treatment of intracranial aneurysm
Type of treatment
Medical device
How many people
1,275 participants
Where
22 sitesFrance
Study dates
Nov 2013to Mar 2019
Phase
Observational
Are there results?
None posted in the registry

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • Centre Hospitalier Universitaire de Besançon

    Besançon, 25030

  • CHU de Bordeaux

    Bordeaux, 33404

  • CHU de CAEN

    Caen, 14000

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

  • AP-HP, Hôpital Beaujon

    Clichy, 92110

  • AP-HP, Hôpital Henri Mondor

    Créteil, 94000

  • CHU de Dijon

    Dijon, 21079

  • CHRU de LILLE

    Lille, 59037

  • Hospices Civils de Lyon

    Lyon, 69002

  • CHU de MONTPELLIER

    Montpellier, 34295

  • CHU de Nancy

    Nancy, 54035

  • CHU de Nantes

    Nantes, 44093

  • CHU de Nice

    Nice, 06003

  • Centre Hospitalier Sainte-Anne

    Paris, 75014

  • AP-HP (Hôpital Pitié Salpétrière)

    Paris

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Centre Hospitalier Universitaire de Reims

    Reims, 51092

  • CHU de Rennes

    Rennes, 35033

  • CHU de Saint-Etienne

    Saint-Etienne, 42055

  • Hopital Foch

    Suresnes, 92151

  • CHU de Toulouse

    Toulouse, 31059

  • CHU de Tours

    Tours, 37044

Other trials in France

About this study

Official title: Evaluation of Risk Factors Associated With Intracranial Aneurysm Recanalization After Endovascular Treatment

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).

Being tested
Endovascular treatment of intracranial aneurysm
Keywords
Intracranial Aneurysm - Endovascular treatment -, Coiling - Stenting - Flow diversion - Flow disruption -, Recanalization - Risk factors
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular treatment of intracranial aneurysmDevice

Study groups in NCT01942512
Study groupRoleWhat they receive
ARETAAll patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Receives: Device: Endovascular treatment of intracranial aneurysm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. aneurysm recanalization

    Measured: assessed at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion23 Jun 2017
  4. Study completionMar 2019

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
Cohort
Time perspective
Prospective
Enrolment
1,275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01942512
Sponsor's protocol ID
PN12145
Acronym
ARETA
Status last verified
May 2019
First submitted
11 Sep 2013
Last updated
10 May 2019
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by CHU de Reims at 22 sites 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

aneurysm recanalization (time frame: assessed at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942512, which also lists 5 linked publications.

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 10 May 2019.

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