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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NeuroFlo™ Catheter
Sponsored by
CoAxia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring acute, ischemic, stroke, device, treatment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA
  • Massachusetts General Hospital
  • University of Rochester
  • University of North Carolina
  • University of Pittsburgh
  • University of Calgary
  • University of Alberta
  • University of Erlangen
  • University of Essen
  • CHUV Lausanne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
February 16, 2007
Last Updated
February 3, 2009
Sponsor
CoAxia
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1. Study Identification

Unique Protocol Identification Number
NCT00436592
Brief Title
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Acronym
Flo 24
Official Title
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CoAxia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
acute, ischemic, stroke, device, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NeuroFlo™ Catheter
Intervention Description
45 minute Treatment
Primary Outcome Measure Information:
Title
Assessment of all adverse events from baseline to 30 days post-treatment.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flo 24 Steering Committee
Organizational Affiliation
Multiple Organizations
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Erlangen
City
Erlangen
Country
Germany
Facility Name
University of Essen
City
Essen
Country
Germany
Facility Name
CHUV Lausanne
City
Lausanne
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22264202
Citation
Hammer MD, Schwamm L, Starkman S, Schellinger PD, Jovin T, Nogueira R, Burgin WS, Sen S, Diener HC, Watson T, Michel P, Shuaib A, Dillon W, Liebeskind DS. Safety and feasibility of NeuroFlo use in eight- to 24-hour ischemic stroke patients. Int J Stroke. 2012 Dec;7(8):655-61. doi: 10.1111/j.1747-4949.2011.00719.x. Epub 2012 Jan 20.
Results Reference
derived
Links:
URL
http://www.coaxia.com
Description
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