Ignite Creation Date:
2024-05-05 @ 10:03 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01029938
Status:
UNKNOWN
Last Update Posted:
2010-07-23
First Post:
2009-12-08
Brief Title:
Treatment of Cranial Internal Carotid Artery Aneurysm With Willis Covered Stent and Coil Embolization
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Comparative Study of Covered Stent With Coil Embolization in the Treatment of Cranial Internal Carotid Artery Aneurysm A Nonrandomized Prospective Trial
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Intracranial aneurysm treatment with coil embolization is associated with relatively low complete occlusion and high recanalization rates The investigators evaluate whether Willis covered stent implantation yields angiographic and clinical results superior to those with coil embolization
Detailed Description:
Endovascular treatment of intracranial aneurysms with detachable coils has been widely used since the introduction of GDCs in 1991 and has been proven to be effective in preventing rebleeding after aneurysmal rupture The clinical and angiographic results of endovascular coil occlusion of intracranial aneurysms are positive with an initial and final overall complete occlusion rate of 359-768 and 383- 878 In the mid- and long-term however aneurysm recanalization may occur in as many as one-third of cases
The natural history of aneurysm recurrence after coil treatment is often benign but bleeding from incompletely coiled aneurysms is a well-documented threat moreover the degree of aneurysm occlusion after treatment was strongly associated with risk of rerupture Even if 100 occlusion of the aneurysms after the initial treatment was obtained on immediate postembolization angiography there was still a relatively high recanalization rate 264 on long-term follow-up angiography In a recent study we have confirmed that there was still aneurysm perfusion of the aneurysm sac in a complete occluded aneurysm no matter on initial or follow-up rotate digital angiography In addition some authors have demonstrated that endothelialization of the aneurysm orifice following placement of GDCs can occur however it appears to be the exception rather than the rule
To overcome these disadvantages the Willis covered stent specially designed for intracranial vasculature has been developed by our institution and the MicroPort Medical Company Micro-Port Shanghai China Our preliminary results demonstrated good flexibility and efficacy of the Willis covered stent in the treatment of cranial internal carotid artery aneurysms CICA in patients without an extremely tortuous ICA Radiology 2009 253470-7 and also the covered stents have been proved to be more effective than re-coiling with regard to complete occlusion of recurrent aneurysms J Neurol Neurosurg Psychiatry 200916Epub ahead of print Since 2005 we have performed a nonrandomized prospective trial of endovascular treatment CICA aneurysms with a covered stenting or coil embolization So we evaluate whether implantation of a primary Willis covered stent yielded angiographic and clinical results that superior to those with the currently recommended approach of coil embolization
The natural history of aneurysm recurrence after coil treatment is often benign but bleeding from incompletely coiled aneurysms is a well-documented threat moreover the degree of aneurysm occlusion after treatment was strongly associated with risk of rerupture Even if 100 occlusion of the aneurysms after the initial treatment was obtained on immediate postembolization angiography there was still a relatively high recanalization rate 264 on long-term follow-up angiography In a recent study we have confirmed that there was still aneurysm perfusion of the aneurysm sac in a complete occluded aneurysm no matter on initial or follow-up rotate digital angiography In addition some authors have demonstrated that endothelialization of the aneurysm orifice following placement of GDCs can occur however it appears to be the exception rather than the rule
To overcome these disadvantages the Willis covered stent specially designed for intracranial vasculature has been developed by our institution and the MicroPort Medical Company Micro-Port Shanghai China Our preliminary results demonstrated good flexibility and efficacy of the Willis covered stent in the treatment of cranial internal carotid artery aneurysms CICA in patients without an extremely tortuous ICA Radiology 2009 253470-7 and also the covered stents have been proved to be more effective than re-coiling with regard to complete occlusion of recurrent aneurysms J Neurol Neurosurg Psychiatry 200916Epub ahead of print Since 2005 we have performed a nonrandomized prospective trial of endovascular treatment CICA aneurysms with a covered stenting or coil embolization So we evaluate whether implantation of a primary Willis covered stent yielded angiographic and clinical results that superior to those with the currently recommended approach of coil embolization
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SAPH002 | None | None | None |