Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01942512
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2013-09-11
Brief Title:
Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Evaluation of Risk Factors Associated With Intracranial Aneurysm Recanalization After Endovascular Treatment
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARETA
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
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 andor 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 11 in case of complete occlusion 29 when aneurysm occlusion is between 91 and 99 59 when aneurysm occlusion is between 70 et 90 and 176 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
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 11 in case of complete occlusion 29 when aneurysm occlusion is between 91 and 99 59 when aneurysm occlusion is between 70 et 90 and 176 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None