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
  Purpose

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 Intervention Phase
Cerebrovascular Accident
Device: NeuroFlo™ catheter
Other: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

Resource links provided by NLM:


Further study details as provided by CoAxia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 515
Study Start Date: June 2005
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: NeuroFlo™ catheter
45 minute treatment
Active Comparator: 2 Other: Control
ASA Guidelines

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119717

  Show 72 Study Locations
Sponsors and Collaborators
CoAxia
Investigators
Principal Investigator: Ashfaq Shuaib, MD University of Alberta, Edmonton
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ashfaq Shuaib, MD, University of Alberta, Edmonton
ClinicalTrials.gov Identifier: NCT00119717     History of Changes
Other Study ID Numbers: CD-0125
Study First Received: July 7, 2005
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health

Keywords provided by CoAxia:
acute
ischemic
stroke
randomized
device
treatment

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014