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

This study has been completed.
Sponsor:
Information provided by:
CoAxia
ClinicalTrials.gov Identifier:
NCT00119717
First received: July 7, 2005
Last updated: May 16, 2011
Last verified: May 2011
History of Changes

July 7, 2005
May 16, 2011
June 2005
June 2010   (final data collection date for primary outcome measure)
  • The safety of the NeuroFlo device and procedure will be compared to medical management alone [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Efficacy will be assessed using a global outcome score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • The safety of the NeuroFlo device and procedure will be compared to medical management alone
  • Efficacy will be assessed at 90 days using a global outcome score.
  • All adverse events out to 90 days will be reported
Complete list of historical versions of study NCT00119717 on ClinicalTrials.gov Archive Site
  • Acute improvement in neurological function [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: 30 & 90 days ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Varies ] [ Designated as safety issue: No ]
  • Patient disposition upon discharge will be compared [ Time Frame: Varies ] [ Designated as safety issue: No ]
  • Acute improvement in neurological function at 24 hrs
  • Stoke Impact Scale at 30 & 90 days
  • Relationship of perfusion augmentation to device treatment
  • Hospital length of stay
  • Patient disposition upon discharge will be compared.
Not Provided
Not Provided
 
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

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.

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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cerebrovascular Accident
  • Device: NeuroFlo™ catheter
    45 minute treatment
  • Other: Control
    ASA Guidelines
  • Experimental: 1
    Intervention: Device: NeuroFlo™ catheter
  • Active Comparator: 2
    Intervention: Other: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
515
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   Germany,   Hungary,   Israel,   Puerto Rico,   Spain,   Switzerland
 
NCT00119717
CD-0125
Yes
Ashfaq Shuaib, MD, University of Alberta, Edmonton
CoAxia
Not Provided
Principal Investigator: Ashfaq Shuaib, MD University of Alberta, Edmonton
CoAxia
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP