NCT01942512

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

3.6 years

First QC Date

September 11, 2013

Last Update Submit

May 9, 2019

Conditions

Intracranial Aneurysm

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • aneurysm recanalization

    assessed at 12 months

Study Arms (1)

ARETA

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

Device: Endovascular treatment of intracranial aneurysm

Interventions

Endovascular treatment of intracranial aneurysmDEVICE
ARETA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

Location

CHU de Bordeaux

Bordeaux, 33404, France

Location

CHU de CAEN

Caen, 14000, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

AP-HP, Hôpital Beaujon

Clichy, 92110, France

Location

AP-HP, Hôpital Henri Mondor

Créteil, 94000, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHRU de LILLE

Lille, 59037, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

CHU de MONTPELLIER

Montpellier, 34295, France

Location

CHU de Nancy

Nancy, 54035, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, 06003, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

AP-HP (Hôpital Pitié Salpétrière)

Paris, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier Universitaire de Reims

Reims, 51092, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Hopital Foch

Suresnes, 92151, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

CHU de Tours

Tours, 37044, France

Location

Related Publications (5)

  • 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.

    PMID: 34740986DERIVED

  • 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.

    PMID: 33443137DERIVED

  • 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.

    PMID: 32895321DERIVED

  • 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.

    PMID: 32546636DERIVED

  • 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.

    PMID: 31539582DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 16, 2013

Study Start

November 1, 2013

Primary Completion

June 23, 2017

Study Completion

March 1, 2019

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations

FR(22)