Cerebrovascular AccidentPhase 3SENTISNCT00119717
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
A Phase 3 study testing NeuroFlo™ catheter in people with Cerebrovascular Accident, run by CoAxia at 72 sites in 10 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- NeuroFlo™ catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 72 sitesin 10 countries
- Study dates
- Jun 2005to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke
- NIHSS between 5-18
- Time from symptom onset less than 14 hours
Who cannot join
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Trial locations and contacts
72 sites in 10 countries.
72 sites in 10 countries
United States47 sites
Albany Medical Center
Albany, New York, 12208
Brackenridge Hospital/Seton Medical Center
Austin, Texas, 78759
Maimonides Medical Center
Brooklyn, New York, 11219
Univeristy of North Carolina
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
Presbyterian Hospital
Charlotte, North Carolina, 28233
Morton Plant Hospital
Clearwater, Florida, 33756
Cleveland Clinic
Cleveland, Ohio, 44195
JFK Medical Center
Edison, New Jersey, 08818
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
The Queen's Medical Center
Honolulu, Hawaii, 96813
Methodist Hospital
Houston, Texas, 77030
Huntsville Hospital
Huntsville, Alabama, 35801
University of Florida
Jacksonville, Florida, 32209
St. Luke's Hospital
Kansas City, Missouri, 64111
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
Michigan State University
Lansing, Michigan, 48824
Sunrise Medical Center
Las Vegas, Nevada, 89109
Central Baptist Hospital
Lexington, Kentucky, 40503
UCLA
Los Angeles, California, 90024
University of Louisville
Louisville, Kentucky, 40202
Univ. of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
St. Thomas Hospital
Nashville, Tennessee, 37205
Vanderbilt University
Nashville, Tennessee, 37232
Munroe Regional Medical Center
Ocala, Florida, 34471
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
St. Joseph Mercy - Oakland
Pontiac, Michigan, 48341
Neurological Associates/CJW Med Ctr
Richmond, Virginia, 23226
Rochester General Hospital
Rochester, New York, 14621
University of Rochester
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Good Samaritan Hospital
San Jose, California, 95124
Sarasota Memorial Hospital
Sarasota, Florida, 34329
Swedish Medical Center
Seattle, Washington, 98122
Providence Hospital
Southfield, Michigan, 48034
Sacred Heart Medical Center
Springfield, Oregon, 97477
St. Louis University
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
SUNY-Upstate Medical Univ.
Syracuse, New York, 13210
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454
Winchester Medical Center
Winchester, Virginia, 22601
Central DuPage Hospital
Winfield, Illinois, 60190
Germany6 sites
Klinikum Köln-Merheim
Cologne
Universitatsklinikum Erlangen
Erlangen
Universitatsklinikum Duisberg-Essen
Essen
Universitätsklinikum Heidelberg
Heidelberg
Universitatsklinikum Mannheim
Mannheim
Dr. Horst Schmidt Kliniken
Wiesbaden
Israel4 sites
Rambam Medical Center
Haifa
Hadassah Hebrew University
Jerusalem
Sourasky Medical Center
Tel Aviv
Chaim Sheba Medical Center
Tel HaShomer
Austria3 sites
AKH General Hospital
Linz
Christian-Doppler-Klinik
Salzburg
Donauklinikum Tulln
Tulln
Belgium3 sites
ZNA Middelheim
Antwerp
AZ St Jan Brugge
Bruges
UZ Gasthuisberg
Leuven
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
University of Western Ontario
London, Ontario, N6A 5A5
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Spain2 sites
Hospital Germans Trias i Pujol
Badalona
Hospital Universitari Vall d'Hebron
Barcelona
Hungary1 site
Medical Health and Science Center, University Of Debrecen
Debrecen
About this study
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
- Cerebrovascular Accident
- Being tested
- NeuroFlo™ catheter, Control
- Keywords
- acute, ischemic, stroke, randomized, device, treatment
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroFlo™ catheterDevice
45 minute treatment
ControlOther
ASA Guidelines
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: NeuroFlo™ catheter |
| 2 | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of the NeuroFlo device and procedure will be compared to medical management alone
Measured: 90 days
Efficacy will be assessed using a global outcome score
Measured: 90 days
Secondary outcomes (4)
Acute improvement in neurological function
Measured: 24 hours
Stroke Impact Scale
Measured: 30 & 90 days
Hospital length of stay
Measured: Varies
Patient disposition upon discharge will be compared
Measured: Varies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoAxia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ashfaq Shuaib, MD, Principal investigator, University of Alberta, Edmonton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119717
- Sponsor's protocol ID
- CD-0125
- Acronym
- SENTIS
- Status last verified
- May 2011
- First submitted
- 7 Jul 2005
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21566232Schellinger 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 23828106Schellinger 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 23549132Shuaib 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
- ClinicalTrials.gov ID
- NCT00119717
- Acronym / sponsor ID
- SENTIS / CD-0125
- Conditions
- Cerebrovascular Accident
- Keywords
- acute, ischemic, stroke, randomized, device, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- CoAxiaIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: NeuroFlo™ catheter |
| 2 | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic stroke
- NIHSS between 5-18
- Time from symptom onset less than 14 hours
Key exclusion criteria (4 listed)
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroFlo™ catheter45 minute treatment | Device | 1 |
| ControlASA Guidelines | Other | 2 |
Primary outcome
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
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- Results publication: PubMed 21566232Shuaib 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.
- Derived from this study: PubMed 23828106Schellinger 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.
- Derived from this study: PubMed 23549132Schellinger 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.
- Derived from this study: PubMed 23291425Shuaib 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashfaq Shuaib, MD principal investigator
University of Alberta, Edmonton
72 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NeuroFlo™ catheter in people with Cerebrovascular Accident, run by CoAxia at 72 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Germany, Israel, Austria, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of the NeuroFlo device and procedure will be compared to medical management alone (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00119717, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.