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Completed

NCT Number: NCT00436592

Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients

The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

The study is a prospective, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours.

A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian & European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ischemic stroke
  • NIHSS between 4-20
  • Time from symptom onset between 8 and 24 hours

Exclusion criteria

  • Hemorrhagic stroke
  • Certain types of heart disease
  • Kidney disease
  • Other conditions the doctor will assess

Treatment and study plan

NeuroFlo™ Catheter

Device

45 minute Treatment

Primary outcomes

  1. Assessment of all adverse events from baseline to 30 days post-treatment.

    Time frame: 30 Days

Secondary outcomes

  1. Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.

    Time frame: 90 Days

  2. Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.

    Time frame: ≤ 4 hours

Sponsors and collaborators

Lead sponsor

CoAxia

Industry

Registry information

Acronym: Flo 24

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 19, 2007
Registry last updated
Feb 5, 2009

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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