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

Cerebrovascular Accident Clinical Trial

— Flo 24  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436592
• Other study ID #: CD-0240
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2007
• Last updated: February 3, 2009
• Start date: February 2007
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: CoAxia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• NeuroFlo™ Catheter
45 minute Treatment

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Germany	University of Erlangen	Erlangen
Germany	University of Essen	Essen
Switzerland	CHUV Lausanne	Lausanne
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	UCLA	Los Angeles	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
CoAxia

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of all adverse events from baseline to 30 days post-treatment.		30 Days	Yes
Secondary	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	No
Secondary	Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and = 4 hours post-procedure.		= 4 hours	No

External Links

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