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

NCT ID: NCT01006993

Last Updated: 2010-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-01-31

Brief Summary

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

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NeuroFlo Treatment

Group Type EXPERIMENTAL

NeuroFlo catheter

Intervention Type DEVICE

NeuroFlo™ catheter 45 minute treatment

Interventions

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NeuroFlo catheter

NeuroFlo™ catheter 45 minute treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CoAxia

INDUSTRY

Sponsor Role lead

Responsible Party

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CoAxia, Inc.

Principal Investigators

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FASTFlo Steering Committee

Role: STUDY_DIRECTOR

Various

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

University of Western Ontario

London, Ontario, Canada

Site Status

Trillium Health Centre

Mississauga, Ontario, Canada

Site Status

University of Erlangen

Erlangen, , Germany

Site Status

Countries

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Canada Germany

References

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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.

Reference Type DERIVED
PMID: 21350210 (View on PubMed)

Other Identifiers

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CD-0258

Identifier Type: -

Identifier Source: org_study_id

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