Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-02 @ 11:20 AM
Study NCT ID:
NCT00436592
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2007-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Sponsor:
CoAxia
Organization:
Study Overview
Official Title:
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Status:
COMPLETED
Status Verified Date:
2009-02
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:
Flo 24
Brief Summary:
The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.
Detailed Description:
The study is a prospective, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours.
A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian \& European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.
A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian \& European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.
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?: