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

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

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.

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.

Inclusion Criteria:

• Ischemic stroke
• NIHSS between 4-20
• Time from symptom onset between 8 and 24 hours

Exclusion Criteria:

• Hemorrhagic stroke
• Certain types of heart disease
• Kidney disease
• Other conditions the doctor will assess