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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00119717
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : May 18, 2011
Information provided by:

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 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

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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00119717

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ashfaq Shuaib, MD, University of Alberta, Edmonton Identifier: NCT00119717     History of Changes
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:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases