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Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients — Flo 24  

Cerebrovascular Accident Clinical Trial

Official title:
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00436592
Study type Interventional
Source CoAxia
Contact
Status Completed
Phase Phase 1
Start date February 2007
Completion date January 2009
View Details
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