Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615882
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Study of Intra-arterial Mechanical Angioplasty Using a SOLITAIRE X Stent for Refractory and Recurrent Vasospasm Mechanical Intracranial Artery DilAtation Using Stent-retriever for Cerebral Vasospasm
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Solitaire-x is a stent-retriever that is currently world-widely used but is currently FDA-approved only as a revascularization device indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke Its utility for mechanical endovascular dilatation for refractory intracranial vasospasm is an off-label indication In this reason we designed single-arm prospective study which aimed to report the safety and effectiveness of Solitaire-X in CV after subarachnoid Prospective exploratory study single arm off label single center study
Detailed Description:
Prospective exploratory study single arm off label single center study I Procedure Intervention
1 Assess the presence and degree of cerebral vasospasm of the target vessel through cerebral angiography before the procedure
2 Solitaire-X stent types are selected
3 During the stent-angioplasty IA nimodipine was also infused
4 Retrieve Solitaire-X after maintaining deployment for 3 minutes
5 Additional procedures are determined through immediate post-procedure and 15-minute delayed cerebral angiography
1 Assess the presence and degree of cerebral vasospasm of the target vessel through cerebral angiography before the procedure
2 Solitaire-X stent types are selected
3 During the stent-angioplasty IA nimodipine was also infused
4 Retrieve Solitaire-X after maintaining deployment for 3 minutes
5 Additional procedures are determined through immediate post-procedure and 15-minute delayed cerebral angiography
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