Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Device: Endovascular treatment of intracranial aneurysm

• Registration Number: NCT01942512
• Lead Sponsor: CHU de Reims

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.

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 Timeline

• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Study Start: 2013-11
• Primary Completion: 2017-06-23
• Study Completion: 2019-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1275

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARETA	Endovascular treatment of intracranial aneurysm	All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

Primary Outcome Measures

Name	Time	Method
aneurysm recanalization	assessed at 12 months

Trial Locations

Locations (22)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besancon, France

Centre Hospitalier Universitaire de Reims; 🇫🇷 Reims, France

CHRU de LILLE; 🇫🇷 Lille, France

CHU de MONTPELLIER; 🇫🇷 Montpellier, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de CAEN; 🇫🇷 Caen, France

AP-HP, Hôpital Beaujon; 🇫🇷 Clichy, France

AP-HP, Hôpital Henri Mondor; 🇫🇷 Creteil, France

Centre Hospitalier Sainte-Anne; 🇫🇷 Paris, France

CHU de Dijon; 🇫🇷 Dijon, France

AP-HP (Hôpital Pitié Salpétrière); 🇫🇷 Paris, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Nice; 🇫🇷 Nice, France

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, France

CHU de Tours; 🇫🇷 Tours, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

Hopital Foch; 🇫🇷 Suresnes, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France