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

This study has been completed.
Sponsor:
Information provided by:
CoAxia
ClinicalTrials.gov Identifier:
NCT00436592
First received: February 16, 2007
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Cerebrovascular Accident
Device: NeuroFlo™ Catheter
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients

Resource links provided by NLM:


Further study details as provided by CoAxia:

Primary Outcome Measures:
  • Assessment of all adverse events from baseline to 30 days post-treatment. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: February 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: NeuroFlo™ Catheter
45 minute Treatment

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.

  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 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
  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: NCT00436592

Locations
United States, California
UCLA
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
Germany
University of Erlangen
Erlangen, Germany
University of Essen
Essen, Germany
Switzerland
CHUV Lausanne
Lausanne, Switzerland
Sponsors and Collaborators
CoAxia
Investigators
Study Chair: Flo 24 Steering Committee Multiple Organizations
  More Information

Additional Information:
No publications provided by CoAxia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Flo 24 Steering Committee, CoAxia
ClinicalTrials.gov Identifier: NCT00436592     History of Changes
Other Study ID Numbers: CD-0240
Study First Received: February 16, 2007
Last Updated: February 3, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by CoAxia:
acute
ischemic
stroke
device
treatment

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014