Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.

Intracranial Aneurysm Clinical Trial

— ARETA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942512
• Other study ID #: PN12145
• Status: Completed
• Start date: November 2013
• Est. completion date: March 2019

Study information

• Verified date: May 2019
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1275
• Est. completion date: March 2019
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Endovascular treatment of intracranial aneurysm

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besancon
France	CHU de Bordeaux	Bordeaux
France	CHU de CAEN	Caen
France	CHU de Clermont-Ferrand	Clermont-ferrand
France	AP-HP, Hôpital Beaujon	Clichy
France	AP-HP, Hôpital Henri Mondor	Creteil
France	CHU de Dijon	Dijon
France	CHRU de LILLE	Lille
France	Hospices Civils de Lyon	Lyon
France	CHU de MONTPELLIER	Montpellier
France	CHU de Nancy	Nancy
France	CHU de Nantes	Nantes
France	CHU de Nice	Nice
France	AP-HP (Hôpital Pitié Salpétrière)	Paris
France	Centre Hospitalier Sainte-Anne	Paris
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Centre Hospitalier Universitaire de Reims	Reims
France	CHU de Rennes	Rennes
France	CHU de Saint-Etienne	Saint-etienne
France	Hopital Foch	Suresnes
France	CHU de Toulouse	Toulouse
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aneurysm recanalization		assessed at 12 months