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

NCT ID: NCT00436592

Last Updated: 2009-02-05

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Cerebrovascular Accident

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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1

Group Type EXPERIMENTAL

NeuroFlo™ Catheter

Intervention Type DEVICE

45 minute Treatment

Interventions

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NeuroFlo™ Catheter

45 minute Treatment

Intervention Type DEVICE

Eligibility Criteria

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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
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

Principal Investigators

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Flo 24 Steering Committee

Role: STUDY_CHAIR

Multiple Organizations

Locations

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UCLA

Los Angeles, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

University of Erlangen

Erlangen, , Germany

Site Status

University of Essen

Essen, , Germany

Site Status

CHUV Lausanne

Lausanne, , Switzerland

Site Status

Countries

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United States Canada Germany Switzerland

References

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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.

Reference Type DERIVED
PMID: 22264202 (View on PubMed)

Related Links

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Other Identifiers

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CD-0240

Identifier Type: -

Identifier Source: org_study_id

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