CompletedNCT00119717SENTISUpdated May 18, 2011

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

A Phase 3 interventional study of NeuroFlo™ catheter and Control in Cerebrovascular Accident, sponsored by CoAxia. Completed at 72 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-18.

Sponsored by CoAxia · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 515
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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:

National Institute of Health Stroke Scale (NIHSS) at baseline (stratify \<10, 11-18)
Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify \<5 hrs, or ≥5 hrs).

Conditions studied

Cerebrovascular Accident

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Keywords

acute
ischemic
stroke
randomized
device
treatment

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 515 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

CoAxia is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Ischemic stroke
NIHSS between 5-18
Time from symptom onset less than 14 hours

Exclusion criteria

Exclusion Criteria:

Hemorrhagic stroke
Certain types of heart disease
Kidney disease
Other conditions the doctor will assess

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 515 participants (actual)

Study arms

Experimental
1
Device: NeuroFlo™ catheter
Active comparator
2
Other: Control

Interventions

DeviceNeuroFlo™ catheter
45 minute treatment
OtherControl
ASA Guidelines

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

72 sites

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
Antwerpen, Belgium
AZ St Jan Brugge
Brugge, 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 Hashomer, 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

References and documents

Publications

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. Erratum In: Stroke. 2011 Nov;42(11):e632-3. PubMed 21566232 ↗
Schellinger 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. PubMed 23828106 ↗
Schellinger 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. PubMed 23549132 ↗
Shuaib 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. PubMed 23291425 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00119717
Lead sponsor: CoAxia
First posted: Jul 14, 2005
Start date: Jun 2005
Primary completion: Jun 2010
Completion: Jul 2010
Last update: May 18, 2011

Study contacts

Ashfaq Shuaib, MD

principal investigator · University of Alberta, Edmonton

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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