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Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator (FASTFlo tPA)

Primary Purpose

Ischemic Stroke

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 Ischemic Stroke

Eligibility Criteria

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

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

Sites / Locations

  • University of Alberta
  • University of Western Ontario
  • Trillium Health Centre
  • University of Erlangen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NeuroFlo Treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2009
Last Updated
March 10, 2010
Sponsor
CoAxia
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1. Study Identification

Unique Protocol Identification Number
NCT01006993
Brief Title
Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator
Acronym
FASTFlo tPA
Official Title
Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CoAxia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
NeuroFlo Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NeuroFlo catheter
Intervention Description
NeuroFlo™ catheter 45 minute treatment
Primary Outcome Measure Information:
Title
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.
Time Frame
Baseline to 30 days post-treatment
Secondary Outcome Measure Information:
Title
Potential patient benefit will be assessed through collection of neurological indices.
Time Frame
Baseline through 90 days

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FASTFlo Steering Committee
Organizational Affiliation
Various
Official's Role
Study Director
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Trillium Health Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 4A2
Country
Canada
Facility Name
University of Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21350210
Citation
Emery DJ, Schellinger PD, Selchen D, Douen AG, Chan R, Shuaib A, Butcher KS. Safety and feasibility of collateral blood flow augmentation after intravenous thrombolysis. Stroke. 2011 Apr;42(4):1135-7. doi: 10.1161/STROKEAHA.110.607846. Epub 2011 Feb 24.
Results Reference
derived

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

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