Viewing Study NCT00119717



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Last Modification Date: 2024-10-26 @ 9:12 AM
Study NCT ID: NCT00119717
Status: COMPLETED
Last Update Posted: 2011-05-18
First Post: 2005-07-07

Brief Title: Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke SENTIS
Sponsor: CoAxia
Organization: CoAxia

Study Overview

Official Title: Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke SENTIS
Status: COMPLETED
Status Verified Date: 2011-05
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: SENTIS
Brief Summary: The purpose of this study is to assess the safety and efficacy of the NeuroFlo catheter for use in patients with ischemic stroke 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 controlled randomized single-blind multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone Randomization will be 11 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters

1 National Institute of Health Stroke Scale NIHSS at baseline stratify 10 11-18
2 Time from symptom onset TFSO to time of baseline NIHSS evaluation stratify 5 hrs or 5 hrs

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