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

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. Identifier: NCT00436592
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : February 5, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: NeuroFlo™ Catheter Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Study Start Date : February 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: 1 Device: NeuroFlo™ Catheter
45 minute Treatment

Primary Outcome Measures :
  1. Assessment of all adverse events from baseline to 30 days post-treatment. [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00436592

United States, California
Los Angeles, California, United States, 90024
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
University of Erlangen
Erlangen, Germany
University of Essen
Essen, Germany
CHUV Lausanne
Lausanne, Switzerland
Sponsors and Collaborators
Study Chair: Flo 24 Steering Committee Multiple Organizations

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Flo 24 Steering Committee, CoAxia Identifier: NCT00436592     History of Changes
Other Study ID Numbers: CD-0240
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by CoAxia:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases