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

Phase 1

Completed

• Conditions: Cerebrovascular Accident
• Interventions: Device: NeuroFlo™ Catheter

• Registration Number: NCT00436592
• Lead Sponsor: CoAxia

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	NeuroFlo™ Catheter	-

Primary Outcome Measures

Name	Time	Method
Assessment of all adverse events from baseline to 30 days post-treatment.	30 Days

Secondary Outcome Measures

Name	Time	Method
Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.	90 Days
Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.	≤ 4 hours

Trial Locations

Locations (10)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

UCLA; 🇺🇸 Los Angeles, California, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Erlangen; 🇩🇪 Erlangen, Germany

University of Essen; 🇩🇪 Essen, Germany

CHUV Lausanne; 🇨🇭 Lausanne, Switzerland

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States