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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NeuroFlo™ catheter
Control
Sponsored by
CoAxia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring acute, ischemic, stroke, randomized, device, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huntsville Hospital
  • UCLA
  • Good Samaritan Hospital
  • Morton Plant Hospital
  • University of Florida
  • Univ. of Miami
  • Munroe Regional Medical Center
  • Sarasota Memorial Hospital
  • The Queen's Medical Center
  • Advocate Lutheran General Hospital
  • Central DuPage Hospital
  • Central Baptist Hospital
  • University of Louisville
  • Michigan State University
  • St. Joseph Mercy - Oakland
  • William Beaumont Hospital
  • Providence Hospital
  • Abbott Northwestern Hospital
  • St. Luke's Hospital
  • St. Louis University
  • Washington University
  • Sunrise Medical Center
  • JFK Medical Center
  • Albany Medical Center
  • Maimonides Medical Center
  • Rochester General Hospital
  • University of Rochester
  • SUNY-Upstate Medical Univ.
  • Univeristy of North Carolina
  • Presbyterian Hospital
  • Moses H. Cone Memorial Hospital
  • Cleveland Clinic
  • Sacred Heart Medical Center
  • Penn State Hershey Medical Center
  • Lancaster General Hospital
  • University of Pittsburgh
  • Medical University of South Carolina
  • Wellmont Holston Valley Medical Center
  • St. Thomas Hospital
  • Vanderbilt University
  • Brackenridge Hospital/Seton Medical Center
  • Methodist Hospital
  • Neurological Associates/CJW Med Ctr
  • Sentara Virginia Beach General Hospital
  • Winchester Medical Center
  • Swedish Medical Center
  • Medical College of Wisconsin
  • AKH General Hospital
  • Christian-Doppler-Klinik
  • Donauklinikum Tulln
  • ZNA Middelheim
  • AZ St Jan Brugge
  • UZ Gasthuisberg
  • University of Alberta Hospital
  • University of Western Ontario
  • Trillium Health Centre
  • Klinikum Köln-Merheim
  • Universitatsklinikum Erlangen
  • Universitatsklinikum Duisberg-Essen
  • Universitätsklinikum Heidelberg
  • Universitatsklinikum Mannheim
  • Dr. Horst Schmidt Kliniken
  • Medical Health and Science Center, University Of Debrecen
  • Rambam Medical Center
  • Hadassah Hebrew University
  • Sourasky Medical Center
  • Chaim Sheba Medical Center
  • University of Puerto Rico
  • Hospital Germans Trias i Pujol
  • Hospital Universitari Vall d'Hebron
  • InselSpital
  • CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acute improvement in neurological function
Stroke Impact Scale
Hospital length of stay
Patient disposition upon discharge will be compared

Full Information

First Posted
July 7, 2005
Last Updated
May 16, 2011
Sponsor
CoAxia
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1. Study Identification

Unique Protocol Identification Number
NCT00119717
Brief Title
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Acronym
SENTIS
Official Title
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CoAxia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
acute, ischemic, stroke, randomized, device, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
515 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
NeuroFlo™ catheter
Intervention Description
45 minute treatment
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
ASA Guidelines
Primary Outcome Measure Information:
Title
The safety of the NeuroFlo device and procedure will be compared to medical management alone
Time Frame
90 days
Title
Efficacy will be assessed using a global outcome score
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Acute improvement in neurological function
Time Frame
24 hours
Title
Stroke Impact Scale
Time Frame
30 & 90 days
Title
Hospital length of stay
Time Frame
Varies
Title
Patient disposition upon discharge will be compared
Time Frame
Varies

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashfaq Shuaib, MD
Organizational Affiliation
University of Alberta, Edmonton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsville Hospital
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34329
Country
United States
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Michigan State University
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
St. Joseph Mercy - Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sunrise Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY-Upstate Medical Univ.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Univeristy of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233
Country
United States
Facility Name
Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Sacred Heart Medical Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Brackenridge Hospital/Seton Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Neurological Associates/CJW Med Ctr
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Sentara Virginia Beach General Hospital
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
AKH General Hospital
City
Linz
Country
Austria
Facility Name
Christian-Doppler-Klinik
City
Salzburg
Country
Austria
Facility Name
Donauklinikum Tulln
City
Tulln
Country
Austria
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Facility Name
AZ St Jan Brugge
City
Brugge
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Trillium Health Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Klinikum Köln-Merheim
City
Cologne
Country
Germany
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitatsklinikum Duisberg-Essen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitatsklinikum Mannheim
City
Mannheim
Country
Germany
Facility Name
Dr. Horst Schmidt Kliniken
City
Wiesbaden
Country
Germany
Facility Name
Medical Health and Science Center, University Of Debrecen
City
Debrecen
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Hebrew University
City
Jerusalem
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
InselSpital
City
Bern
Country
Switzerland
Facility Name
CHUV
City
Lausanne
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21566232
Citation
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.
Results Reference
result
PubMed Identifier
23828106
Citation
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.
Results Reference
derived
PubMed Identifier
23549132
Citation
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.
Results Reference
derived
PubMed Identifier
23291425
Citation
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.
Results Reference
derived
Links:
URL
http://www.coaxia.com
Description
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Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

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