Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator (FASTFlo tPA)

March 10, 2010 updated by: CoAxia

Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University of Western Ontario
      • Mississauga, Ontario, Canada, L5B 4A2
        • Trillium Health Centre
  • Germany
      • Erlangen, Germany, 91054
        • University of Erlangen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroFlo Treatment
Device: NeuroFlo catheter
NeuroFlo™ catheter 45 minute treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.
Time Frame: Baseline to 30 days post-treatment
Baseline to 30 days post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Potential patient benefit will be assessed through collection of neurological indices.
Time Frame: Baseline through 90 days
Baseline through 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoAxia

Investigators

  • Study Director: FASTFlo Steering Committee, Various

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 2, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 11, 2010

Last Update Submitted That Met QC Criteria

March 10, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-0258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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