Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator

Phase 1

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: NeuroFlo catheter

• Registration Number: NCT01006993
• Lead Sponsor: CoAxia

Brief Summary

To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2009-07
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Study Completion: 2010-01
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-10
• Last Update Posted: 2010-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Ischemic stroke
• NIHSS between 5-22
• Persistent clinical deficits following administration of rt-PA

Exclusion Criteria

• Planned thrombectomy
• Aortic pathology
• Severe heart disease
• Other conditions the doctor will assess

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuroFlo Treatment	NeuroFlo catheter	-

Primary Outcome Measures

Name	Time	Method
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.	Baseline to 30 days post-treatment

Secondary Outcome Measures

Name	Time	Method
Potential patient benefit will be assessed through collection of neurological indices.	Baseline through 90 days

Trial Locations

Locations (4)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Erlangen; 🇩🇪 Erlangen, Germany

University of Western Ontario; 🇨🇦 London, Ontario, Canada

Trillium Health Centre; 🇨🇦 Mississauga, Ontario, Canada