Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 10:28 PM
Study NCT ID:
NCT01502761
Status:
TERMINATED
Last Update Posted:
2017-08-28
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra-arterial Magnesium Administration for Acute Stroke
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No safety issues. Low enrollment secondary to negative stroke studies 2013
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is the second leading cause of death and the leading cause of adult disability worldwide. This investigation will address the safety and feasibility of directed, intra-arterial Magnesium measurement and therapy, through endovascular access, in acute stroke patients. The proposal represents the first study to directly quantify levels of a systemically administered neuroprotectant in the region of cerebral ischemia. It also establishes a novel endovascular platform for direct delivery of neuroprotective agents to ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve patient care by establishing a novel delivery mechanism for the rescue of threatened brain parenchyma that can be administered rapidly following acute stroke. If successful, this selective distribution will allow delivery to "at risk" tissue in a rapid manner. Salvage of viable, but threatened, penumbral tissue could afford stroke patients an increased probability of favorable long term outcome. The investigators hypothesize that endovascular, intra-arterial, Magnesium administration will deliver high concentration of this neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic concentrations. The proposed investigation will evaluate the safety and feasibility of this novel treatment technique
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: