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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by CHU de Reims.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
CHU de Reims
ClinicalTrials.gov Identifier:
NCT01942512
First received: September 11, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Intracranial Aneurysm
Device: Endovascular treatment of intracranial aneurysm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Risk Factors Associated With Intracranial Aneurysm Recanalization After Endovascular Treatment

Resource links provided by NLM:


Further study details as provided by CHU de Reims:

Primary Outcome Measures:
  • aneurysm recanalization [ Time Frame: assessed at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1275
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ARETA
All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Device: Endovascular treatment of intracranial aneurysm

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942512

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

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT01942512     History of Changes
Other Study ID Numbers: PN12145 
Study First Received: September 11, 2013
Last Updated: August 5, 2014
Health Authority: France: Ministry of Health

Keywords provided by CHU de Reims:
Intracranial Aneurysm - Endovascular treatment -
Coiling - Stenting - Flow diversion - Flow disruption -
Recanalization - Risk factors

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on December 02, 2016