Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
SENTIS
1 other identifier
interventional
515
10 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
Longer than P75 for phase_3
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 7, 2005
CompletedFirst Posted
Study publicly available on registry
July 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMay 18, 2011
May 1, 2011
5 years
July 7, 2005
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Acute improvement in neurological function
24 hours
Stroke Impact Scale
30 & 90 days
Hospital length of stay
Varies
Patient disposition upon discharge will be compared
Varies
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Ischemic stroke
- NIHSS between 5-18
- Time from symptom onset less than 14 hours
You may not qualify if:
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CoAxialead
Study Sites (72)
Huntsville Hospital
Huntsville, Alabama, 35801, United States
UCLA
Los Angeles, California, 90024, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
University of Florida
Jacksonville, Florida, 32209, United States
Univ. of Miami
Miami, Florida, 33136, United States
Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34329, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Michigan State University
Lansing, Michigan, 48824, United States
St. Joseph Mercy - Oakland
Pontiac, Michigan, 48341, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Providence Hospital
Southfield, Michigan, 48034, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
St. Louis University
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
Sunrise Medical Center
Las Vegas, Nevada, 89109, United States
JFK Medical Center
Edison, New Jersey, 08818, United States
Albany Medical Center
Albany, New York, 12208, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Rochester General Hospital
Rochester, New York, 14621, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY-Upstate Medical Univ.
Syracuse, New York, 13210, United States
Univeristy of North Carolina
Chapel Hill, North Carolina, 27514, United States
Presbyterian Hospital
Charlotte, North Carolina, 28233, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Sacred Heart Medical Center
Springfield, Oregon, 97477, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
St. Thomas Hospital
Nashville, Tennessee, 37205, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Brackenridge Hospital/Seton Medical Center
Austin, Texas, 78759, United States
Methodist Hospital
Houston, Texas, 77030, United States
Neurological Associates/CJW Med Ctr
Richmond, Virginia, 23226, United States
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
AKH General Hospital
Linz, Austria
Christian-Doppler-Klinik
Salzburg, Austria
Donauklinikum Tulln
Tulln, Austria
ZNA Middelheim
Antwerp, Belgium
AZ St Jan Brugge
Bruges, Belgium
UZ Gasthuisberg
Leuven, Belgium
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
University of Western Ontario
London, Ontario, N6A 5A5, Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8, Canada
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 Litwinsky, Israel
University of Puerto Rico
San Juan, 00935, Puerto Rico
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
InselSpital
Bern, Switzerland
CHUV
Lausanne, Switzerland
Related Publications (4)
Shuaib A, Bornstein NM, Diener HC, Dillon W, Fisher M, Hammer MD, Molina CA, Rutledge JN, Saver JL, Schellinger PD, Shownkeen H; SENTIS Trial Investigators. Partial aortic occlusion for cerebral perfusion augmentation: safety and efficacy of NeuroFlo in Acute Ischemic Stroke trial. Stroke. 2011 Jun;42(6):1680-90. doi: 10.1161/STROKEAHA.110.609933. Epub 2011 May 12.
PMID: 21566232RESULTSchellinger PD, Shuaib A, Kohrmann M, Liebeskind DS, Jovin T, Hammer MD, Sen S, Huang DY, Solander S, Gupta R, Leker RR, Saver JL; SENTIS Trial Investigators. Reduced mortality and severe disability rates in the SENTIS trial. AJNR Am J Neuroradiol. 2013 Dec;34(12):2312-6. doi: 10.3174/ajnr.A3613. Epub 2013 Jul 4.
PMID: 23828106DERIVEDSchellinger PD, Kohrmann M, Liu S, Dillon WP, Nogueira RG, Shuaib A, Liebeskind DS; SENTIS Trial Investigators. Favorable vascular profile is an independent predictor of outcome: a post hoc analysis of the safety and efficacy of NeuroFlo Technology in Ischemic Stroke trial. Stroke. 2013 Jun;44(6):1606-8. doi: 10.1161/STROKEAHA.111.000709. Epub 2013 Apr 2.
PMID: 23549132DERIVEDShuaib A, Schwab S, Rutledge JN, Starkman S, Liebeskind DS, Bernardini GL, Boulos A, Abou-Chebl A, Huang DY, Vanhooren G, Cruz-Flores S, Klucznik RP, Saver JL; SENTIS trial investigators. Importance of proper patient selection and endpoint selection in evaluation of new therapies in acute stroke: further analysis of the SENTIS trial. J Neurointerv Surg. 2013 May;5 Suppl 1(0 1):i21-4. doi: 10.1136/neurintsurg-2012-010562. Epub 2013 Jan 3.
PMID: 23291425DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashfaq Shuaib, MD
University of Alberta, Edmonton
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2005
First Posted
July 14, 2005
Study Start
June 1, 2005
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
May 18, 2011
Record last verified: 2011-05