- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00436592
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients (Flo 24)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- University of Calgary
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta
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Erlangen, Germany
- University of Erlangen
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Essen, Germany
- University of Essen
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Lausanne, Switzerland
- CHUV Lausanne
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California
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Los Angeles, California, United States, 90024
- UCLA
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
45 minute Treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of all adverse events from baseline to 30 days post-treatment.
Time Frame: 30 Days
|
30 Days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
90 Days
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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
|
≤ 4 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Flo 24 Steering Committee, Multiple Organizations
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD-0240
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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