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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01942512
Other study ID # PN12145
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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