Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
- Conditions
- Cerebrovascular Accident
- Interventions
- Device: NeuroFlo™ catheterOther: Control
- Registration Number
- NCT00119717
- Lead Sponsor
- CoAxia
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 515
- Ischemic stroke
- NIHSS between 5-18
- Time from symptom onset less than 14 hours
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 NeuroFlo™ catheter - 2 Control -
- Primary Outcome Measures
Name Time Method The safety of the NeuroFlo device and procedure will be compared to medical management alone 90 days Efficacy will be assessed using a global outcome score 90 days
- Secondary Outcome Measures
Name Time Method Acute improvement in neurological function 24 hours Hospital length of stay Varies Stroke Impact Scale 30 & 90 days Patient disposition upon discharge will be compared Varies
Trial Locations
- Locations (72)
St. Joseph Mercy - Oakland
🇺🇸Pontiac, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Michigan State University
🇺🇸Lansing, Michigan, United States
Good Samaritan Hospital
🇺🇸San Jose, California, United States
Sentara Virginia Beach General Hospital
🇺🇸Virginia Beach, Virginia, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Univ. of Miami
🇺🇸Miami, Florida, United States
Klinikum Köln-Merheim
🇩🇪Cologne, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Sacred Heart Medical Center
🇺🇸Springfield, Oregon, United States
SUNY-Upstate Medical Univ.
🇺🇸Syracuse, New York, United States
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Universitatsklinikum Duisberg-Essen
🇩🇪Essen, Germany
Moses H. Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Universitatsklinikum Erlangen
🇩🇪Erlangen, Germany
Dr. Horst Schmidt Kliniken
🇩🇪Wiesbaden, Germany
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Universitatsklinikum Mannheim
🇩🇪Mannheim, Germany
University of Western Ontario
🇨🇦London, Ontario, Canada
UCLA
🇺🇸Los Angeles, California, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
AKH General Hospital
🇦🇹Linz, Austria
Methodist Hospital
🇺🇸Houston, Texas, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Sunrise Medical Center
🇺🇸Las Vegas, Nevada, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Hadassah Hebrew University
🇮🇱Jerusalem, Israel
InselSpital
🇨🇭Bern, Switzerland
Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Donauklinikum Tulln
🇦🇹Tulln, Austria
Rambam Medical Center
🇮🇱Haifa, Israel
JFK Medical Center
🇺🇸Edison, New Jersey, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
ZNA Middelheim
🇧🇪Antwerpen, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Christian-Doppler-Klinik
🇦🇹Salzburg, Austria
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
AZ St Jan Brugge
🇧🇪Brugge, Belgium
Medical Health and Science Center, University Of Debrecen
🇭🇺Debrecen, Hungary
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
CHUV
🇨🇭Lausanne, Switzerland
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Winchester Medical Center
🇺🇸Winchester, Virginia, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Univeristy of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Brackenridge Hospital/Seton Medical Center
🇺🇸Austin, Texas, United States
Neurological Associates/CJW Med Ctr
🇺🇸Richmond, Virginia, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States