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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006993
First Posted: November 3, 2009
Last Update Posted: March 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CoAxia
  Purpose
To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.

Condition Intervention Phase
Ischemic Stroke Device: NeuroFlo catheter Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA

Further study details as provided by CoAxia:

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

Secondary Outcome Measures:
  • Potential patient benefit will be assessed through collection of neurological indices. [ Time Frame: Baseline through 90 days ]

Enrollment: 22
Study Start Date: May 2007
Study Completion Date: January 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeuroFlo Treatment Device: NeuroFlo catheter
NeuroFlo™ catheter 45 minute treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006993


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 4A2
Germany
University of Erlangen
Erlangen, Germany, 91054
Sponsors and Collaborators
CoAxia
Investigators
Study Director: FASTFlo Steering Committee Various
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lori Austin, CoAxia, Inc.
ClinicalTrials.gov Identifier: NCT01006993     History of Changes
Other Study ID Numbers: CD-0258
First Submitted: November 2, 2009
First Posted: November 3, 2009
Last Update Posted: March 11, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action