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Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) (SENTIS)

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ClinicalTrials.gov Identifier: NCT00119717
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
CoAxia

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: NeuroFlo™ catheter Other: Control Phase 3

Detailed Description:

The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters:

  1. National Institute of Health Stroke Scale (NIHSS) at baseline (stratify <10, 11-18)
  2. Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify <5 hrs, or ≥5 hrs).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Study Start Date : June 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Device: NeuroFlo™ catheter
45 minute treatment
Active Comparator: 2 Other: Control
ASA Guidelines


Outcome Measures
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Primary Outcome Measures :
  1. The safety of the NeuroFlo device and procedure will be compared to medical management alone [ Time Frame: 90 days ]
  2. Efficacy will be assessed using a global outcome score [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Acute improvement in neurological function [ Time Frame: 24 hours ]
  2. Stroke Impact Scale [ Time Frame: 30 & 90 days ]
  3. Hospital length of stay [ Time Frame: Varies ]
  4. Patient disposition upon discharge will be compared [ Time Frame: Varies ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic stroke
  • NIHSS between 5-18
  • Time from symptom onset less than 14 hours

Exclusion Criteria:

  • Hemorrhagic stroke
  • Certain types of heart disease
  • Kidney disease
  • Other conditions the doctor will assess
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119717


Locations
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Sponsors and Collaborators
CoAxia
Investigators
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Principal Investigator: Ashfaq Shuaib, MD University of Alberta, Edmonton
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ashfaq Shuaib, MD, University of Alberta, Edmonton
ClinicalTrials.gov Identifier: NCT00119717    
Other Study ID Numbers: CD-0125
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011
Keywords provided by CoAxia:
acute
ischemic
stroke
 randomized
device
treatment
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases