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

Ischemic Stroke Clinical Trial

— FASTFlo tPA  

Official title:

Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006993
• Other study ID #: CD-0258
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2009
• Last updated: March 10, 2010
• Start date: May 2007
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: CoAxia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• NeuroFlo catheter
NeuroFlo™ catheter 45 minute treatment

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Western Ontario	London	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Germany	University of Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
CoAxia

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.		Baseline to 30 days post-treatment	Yes
Secondary	Potential patient benefit will be assessed through collection of neurological indices.		Baseline through 90 days	No