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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
  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)

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

  Hide Study Locations
Locations
United States, Alabama
Huntsville Hospital
Huntsville, Alabama, United States, 35801
United States, California
UCLA
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
Vanderbilt University
Nashville, Tennessee, United States, 37232
St. Thomas Hospital
Nashville, Tennessee, United States, 37205
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
Austria
AKH General Hospital
Linz, Austria
Christian-Doppler-Klinik
Salzburg, Austria
Donauklinikum Tulln
Tulln, Austria
Belgium
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
Germany
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
Hungary
Medical Health and Science Center, University Of Debrecen
Debrecen, Hungary
Israel
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
Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Switzerland
InselSpital
Bern, Switzerland
CHUV
Lausanne, Switzerland
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 Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014