NCT00436592

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: CoAxia · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	NeuroFlo™ Catheter	45 minute Treatment

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-02-19
• Last updated: 2009-02-05

Locations

10 sites across 4 countries: United States, Canada, Germany, Switzerland