SENTIS
Safety and Efficacy of NeuroFlo™ Technology in Ischemic Stroke
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Status:
Ongoing. As of October 1, 2009, 454 patients have been enrolled. Enrollment will continue through early 2010.
Purpose:
To determine if a unique method for increasing blood flow to the brain (with a catheter partially occluding the aorta) can minimize the damage caused by stroke and improve patient outcome.
Interventions:
Catheter
NeuroFlo catheter
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Location(s):
U.S., Canada, Europe, and Israel.
Year Started:
2005
Design:
Prospective, controlled, randomized, single-blind, multicenter trial of NeuroFlo™ treatment plus standard medical management versus standard medical management alone.
Inclusion Criteria
Patients diagnosed with a focal neurological deficit due to ischemia, NIHSS 5-18, who can be treated within 14 hours of symptom onset.
Exclusion Criteria
Patients with hemorrhagic stroke, certain types of heart disease, kidney disease, and other conditions to be assessed by the study doctor.
Patient Involvement:
Participation in the study will last 90 days and involve 2 follow-up visits. Procedures include physical exams, lab work, neurological exams, CT/MR imaging, ECG. The treatment group will also receive an aortogram and NeuroFlo therapy.
Primary Outcome:
Efficacy as measured by neurological improvement; and safety as measured by serious adverse events at 90 days.
Secondary Outcome:
Acute improvement in neurological function 24 hours post-procedure, and comparison of SIS at 30 & 90 days, hospital length of stay, and patient disposition upon discharge.
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Source of Information:
Correspondence with trial sponsor [July 2005].
Presented at the 2006 International Stroke Conference [February 2006].
Correspondence with trial sponsor [March 2006].
Correspondence with trial sponsor [July 2006].
Updated per correspondence with coordinator 11/4/08-jh.
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2008 International Stroke Conference [February 2008].
Presented at the 2009 International Stroke Conference [February 2009].
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Web Links and Publications:
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This information last updated on: 10/5/2009
Reviewed on: 10/05/2009.
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Trials
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