Clinical trial NCT01942512: Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.
Official title: Evaluation of Risk Factors Associated With Intracranial Aneurysm Recanalization After Endovascular Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Intracranial Aneurysm - Endovascular treatment -
Coiling - Stenting - Flow diversion - Flow disruption -
Recanalization - Risk factors
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 1275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with intracranial aneurysms, ruptured or unruptured, treated by endovascular treatment

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).

Eligibility 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

Primary outcomes:
measure: aneurysm recanalization
timeFrame: assessed at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: CHU de CAEN
city: Clermont-ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Clichy
country: France
facility: AP-HP, Hôpital Beaujon
city: Creteil
country: France
facility: AP-HP, Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Lille
country: France
facility: CHRU de LILLE
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: CHU de MONTPELLIER
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne
city: Paris
country: France
facility: AP-HP (Hôpital Pitié Salpétrière)
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
Study officials:
References:
citation: Pierot L, Barbe C, Thierry A, Bala F, Eugene F, Cognard C, Herbreteau D, Velasco S, Chabert E, Desal H, Aggour M, Rodriguez-Regent C, Gallas S, Sedat J, Marnat G, Sourour N, Consoli A, Papagiannaki C, Spelle L, White P. Patient and aneurysm factors associated with aneurysm recanalization after coiling. J Neurointerv Surg. 2022 Nov;14(11):1096-1101. doi: 10.1136/neurintsurg-2021-017972. Epub 2021 Nov 5.
citation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L; From the Departments of Neuroradiology, Research, and Public Health. Immediate post-operative aneurysm occlusion after endovascular treatment of intracranial aneurysms with coiling or balloon-assisted coiling in a prospective multicenter cohort of 1189 patients: Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2021 Oct;13(10):918-923. doi: 10.1136/neurintsurg-2020-017012. Epub 2020 Dec 21.
citation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L. Delayed thromboembolic events after coiling of unruptured intracranial aneurysms in a prospective cohort of 335 patients. J Neurointerv Surg. 2021 Jun;13(6):534-540. doi: 10.1136/neurintsurg-2020-016654. Epub 2020 Sep 7.
citation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L. Rebleeding and bleeding in the year following intracranial aneurysm coiling: analysis of a large prospective multicenter cohort of 1140 patients-Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2020 Dec;12(12):1219-1225. doi: 10.1136/neurintsurg-2020-015971. Epub 2020 Jun 16.
citation: Pierot L, Barbe C, Ferre JC, Cognard C, Soize S, White P, Spelle L. Patient and aneurysm factors associated with aneurysm rupture in the population of the ARETA study. J Neuroradiol. 2020 Jun;47(4):292-300. doi: 10.1016/j.neurad.2019.07.007. Epub 2019 Sep 17.