Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
NCT ID: NCT00436592
Last Updated: 2009-02-05
Study Results
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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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2007-02-28
2009-01-31
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
NeuroFlo™ Catheter
45 minute Treatment
Interventions
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NeuroFlo™ Catheter
45 minute Treatment
Eligibility Criteria
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Inclusion Criteria
* NIHSS between 4-20
* Time from symptom onset between 8 and 24 hours
Exclusion Criteria
* Certain types of heart disease
* Kidney disease
* Other conditions the doctor will assess
18 Years
85 Years
ALL
No
Sponsors
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CoAxia
INDUSTRY
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
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Erlangen
Erlangen, , Germany
University of Essen
Essen, , Germany
CHUV Lausanne
Lausanne, , Switzerland
Countries
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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.
Related Links
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Related Info
Other Identifiers
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CD-0240
Identifier Type: -
Identifier Source: org_study_id
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