Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment. (ARETA)

May 9, 2019 updated by: CHU de Reims

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

1275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARETA
All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Device: Endovascular treatment of intracranial aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
aneurysm recanalization
Time Frame: assessed at 12 months
assessed at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

June 23, 2017

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN12145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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