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

Sponsor
CoAxia (Industry)
Overall Status
Completed
CT.gov ID
NCT00119717
Collaborator
(none)
515
Enrollment
72
Locations
2
Arms
61
Duration (Months)
7.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NeuroFlo™ catheter
  • Other: Control
 Phase 3

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
515 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Device: NeuroFlo™ catheter
45 minute treatment
Active Comparator: 2

Other: Control
ASA Guidelines

Outcome Measures

Primary Outcome Measures

  1. The safety of the NeuroFlo device and procedure will be compared to medical management alone [90 days]

  2. Efficacy will be assessed using a global outcome score [90 days]

Secondary Outcome Measures

  1. Acute improvement in neurological function [24 hours]

  2. Stroke Impact Scale [30 & 90 days]

  3. Hospital length of stay [Varies]

  4. Patient disposition upon discharge will be compared [Varies]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Huntsville Hospital Huntsville Alabama United States 35801
2 UCLA Los Angeles California United States 90024
3 Good Samaritan Hospital San Jose California United States 95124
4 Morton Plant Hospital Clearwater Florida United States 33756
5 University of Florida Jacksonville Florida United States 32209
6 Univ. of Miami Miami Florida United States 33136
7 Munroe Regional Medical Center Ocala Florida United States 34471
8 Sarasota Memorial Hospital Sarasota Florida United States 34329
9 The Queen's Medical Center Honolulu Hawaii United States 96813
10 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
11 Central DuPage Hospital Winfield Illinois United States 60190
12 Central Baptist Hospital Lexington Kentucky United States 40503
13 University of Louisville Louisville Kentucky United States 40202
14 Michigan State University Lansing Michigan United States 48824
15 St. Joseph Mercy - Oakland Pontiac Michigan United States 48341
16 William Beaumont Hospital Royal Oak Michigan United States 48073
17 Providence Hospital Southfield Michigan United States 48034
18 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
19 St. Luke's Hospital Kansas City Missouri United States 64111
20 St. Louis University St. Louis Missouri United States 63110
21 Washington University St. Louis Missouri United States 63110
22 Sunrise Medical Center Las Vegas Nevada United States 89109
23 JFK Medical Center Edison New Jersey United States 08818
24 Albany Medical Center Albany New York United States 12208
25 Maimonides Medical Center Brooklyn New York United States 11219
26 Rochester General Hospital Rochester New York United States 14621
27 University of Rochester Rochester New York United States 14642
28 SUNY-Upstate Medical Univ. Syracuse New York United States 13210
29 Univeristy of North Carolina Chapel Hill North Carolina United States 27514
30 Presbyterian Hospital Charlotte North Carolina United States 28233
31 Moses H. Cone Memorial Hospital Greensboro North Carolina United States 27401
32 Cleveland Clinic Cleveland Ohio United States 44195
33 Sacred Heart Medical Center Springfield Oregon United States 97477
34 Penn State Hershey Medical Center Hershey Pennsylvania United States 17033
35 Lancaster General Hospital Lancaster Pennsylvania United States 17604
36 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
37 Medical University of South Carolina Charleston South Carolina United States 29425
38 Wellmont Holston Valley Medical Center Kingsport Tennessee United States 37660
39 St. Thomas Hospital Nashville Tennessee United States 37205
40 Vanderbilt University Nashville Tennessee United States 37232
41 Brackenridge Hospital/Seton Medical Center Austin Texas United States 78759
42 Methodist Hospital Houston Texas United States 77030
43 Neurological Associates/CJW Med Ctr Richmond Virginia United States 23226
44 Sentara Virginia Beach General Hospital Virginia Beach Virginia United States 23454
45 Winchester Medical Center Winchester Virginia United States 22601
46 Swedish Medical Center Seattle Washington United States 98122
47 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
48 AKH General Hospital Linz Austria
49 Christian-Doppler-Klinik Salzburg Austria
50 Donauklinikum Tulln Tulln Austria
51 ZNA Middelheim Antwerpen Belgium
52 AZ St Jan Brugge Brugge Belgium
53 UZ Gasthuisberg Leuven Belgium
54 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
55 University of Western Ontario London Ontario Canada N6A 5A5
56 Trillium Health Centre Mississauga Ontario Canada L5B 1B8
57 Klinikum Köln-Merheim Cologne Germany
58 Universitatsklinikum Erlangen Erlangen Germany
59 Universitatsklinikum Duisberg-Essen Essen Germany
60 Universitätsklinikum Heidelberg Heidelberg Germany
61 Universitatsklinikum Mannheim Mannheim Germany
62 Dr. Horst Schmidt Kliniken Wiesbaden Germany
63 Medical Health and Science Center, University Of Debrecen Debrecen Hungary
64 Rambam Medical Center Haifa Israel
65 Hadassah Hebrew University Jerusalem Israel
66 Sourasky Medical Center Tel Aviv Israel
67 Chaim Sheba Medical Center Tel Hashomer Israel
68 University of Puerto Rico San Juan Puerto Rico 00935
69 Hospital Germans Trias i Pujol Badalona Spain
70 Hospital Universitari Vall d'Hebron Barcelona Spain
71 InselSpital Bern Switzerland
72 CHUV Lausanne Switzerland

Sponsors and Collaborators

  • CoAxia

Investigators

  • Principal Investigator: Ashfaq Shuaib, MD, University of Alberta, Edmonton

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00119717
Other Study ID Numbers:
  • CD-0125
First Posted:
Jul 14, 2005
Last Update Posted:
May 18, 2011
Last Verified:
May 1, 2011
Keywords provided by , ,
acute
ischemic
stroke
randomized
device
treatment
Additional relevant MeSH terms:
Stroke
Ischemic Stroke

Study Results

No Results Posted as of May 18, 2011