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

This study has been completed.
Sponsor:
Information provided by:
CoAxia
ClinicalTrials.gov Identifier:
NCT01006993
First received: November 2, 2009
Last updated: March 10, 2010
Last verified: March 2010
  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: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Potential patient benefit will be assessed through collection of neurological indices. [ Time Frame: Baseline through 90 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by CoAxia

Additional 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
Study First Received: November 2, 2009
Last Updated: March 10, 2010
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 24, 2014