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

May 16, 2011 updated by: CoAxia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

515

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • AKH General Hospital
      • Salzburg, Austria
        • Christian-Doppler-Klinik
      • Tulln, Austria
        • Donauklinikum Tulln
  • Belgium
      • Antwerpen, Belgium
        • ZNA Middelheim
      • Brugge, Belgium
        • AZ St Jan Brugge
      • Leuven, Belgium
        • Uz Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University of Western Ontario
      • Mississauga, Ontario, Canada, L5B 1B8
        • Trillium Health Centre
  • Germany
      • Cologne, Germany
        • Klinikum Köln-Merheim
      • Erlangen, Germany
        • Universitatsklinikum Erlangen
      • Essen, Germany
        • Universitatsklinikum Duisberg-Essen
      • Heidelberg, Germany
        • UniversitatsKlinikum Heidelberg
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Wiesbaden, Germany
        • Dr. Horst Schmidt Kliniken
  • Hungary
      • Debrecen, Hungary
        • Medical Health and Science Center, University Of Debrecen
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Hebrew University
      • Tel Aviv, Israel
        • Sourasky Medical Center
      • Tel Hashomer, Israel
        • Chaim Sheba Medical Center
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • University of Puerto Rico
  • Spain
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
  • Switzerland
      • Bern, Switzerland
        • Inselspital
      • Lausanne, Switzerland
        • CHUV
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Huntsville Hospital
    • California
      • Los Angeles, California, United States, 90024
        • UCLA
      • San Jose, California, United States, 95124
        • Good Samaritan Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Miami, Florida, United States, 33136
        • Univ. of Miami
      • Ocala, Florida, United States, 34471
        • Munroe Regional Medical Center
      • Sarasota, Florida, United States, 34329
        • Sarasota Memorial Hospital
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Michigan
      • Lansing, Michigan, United States, 48824
        • Michigan State University
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy - Oakland
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Southfield, Michigan, United States, 48034
        • Providence Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • St. Louis, Missouri, United States, 63110
        • Washington University
      • St. Louis, Missouri, United States, 63110
        • St. Louis University
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sunrise Medical Center
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • JFK Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Syracuse, New York, United States, 13210
        • SUNY-Upstate Medical Univ.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Univeristy of North Carolina
      • Charlotte, North Carolina, United States, 28233
        • Presbyterian Hospital
      • Greensboro, North Carolina, United States, 27401
        • Moses H. Cone Memorial Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Sacred Heart Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont Holston Valley Medical Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Hospital
    • Texas
      • Austin, Texas, United States, 78759
        • Brackenridge Hospital/Seton Medical Center
      • Houston, Texas, United States, 77030
        • Methodist Hospital
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Neurological Associates/CJW Med Ctr
      • Virginia Beach, Virginia, United States, 23454
        • Sentara Virginia Beach General Hospital
      • Winchester, Virginia, United States, 22601
        • Winchester Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: NeuroFlo™ catheter
45 minute treatment
Active Comparator: 2
Other: Control
ASA Guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety of the NeuroFlo device and procedure will be compared to medical management alone
Time Frame: 90 days
90 days
Efficacy will be assessed using a global outcome score
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute improvement in neurological function
Time Frame: 24 hours
24 hours
Stroke Impact Scale
Time Frame: 30 & 90 days
30 & 90 days
Hospital length of stay
Time Frame: Varies
Varies
Patient disposition upon discharge will be compared
Time Frame: Varies
Varies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoAxia

Investigators

  • Principal Investigator: Ashfaq Shuaib, MD, University of Alberta, Edmonton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 7, 2005

First Submitted That Met QC Criteria

July 7, 2005

First Posted (Estimate)

July 14, 2005

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-0125

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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