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OpenTrials
Completed

NCT Number: NCT01006993

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

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alberta, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroFlo catheter

Device

NeuroFlo™ catheter 45 minute treatment

Primary outcomes

  1. An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.

    Time frame: Baseline to 30 days post-treatment

Secondary outcomes

  1. Potential patient benefit will be assessed through collection of neurological indices.

    Time frame: Baseline through 90 days

Sponsors and collaborators

Lead sponsor

CoAxia

Industry

Registry information

Official study title

Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA

Acronym: FASTFlo tPA

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Nov 3, 2009
Registry last updated
Mar 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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