Clinical trial NCT00119717: Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Official title: Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrovascular Accident
Keywords: acute
ischemic
stroke
randomized
device
treatment
Lead sponsor: CoAxia
Sponsor class: INDUSTRY
First posted: 2005-07-14
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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).

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

Primary outcomes:
measure: The safety of the NeuroFlo device and procedure will be compared to medical management alone
timeFrame: 90 days
measure: Efficacy will be assessed using a global outcome score
timeFrame: 90 days
Secondary outcomes:
measure: Acute improvement in neurological function
timeFrame: 24 hours
measure: Stroke Impact Scale
timeFrame: 30 & 90 days
measure: Hospital length of stay
timeFrame: Varies
measure: Patient disposition upon discharge will be compared
timeFrame: Varies
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Univ. of Miami
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy - Oakland
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Medical Center
state: Nevada
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Syracuse
country: United States
facility: SUNY-Upstate Medical Univ.
state: New York
city: Chapel Hill
country: United States
facility: Univeristy of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Springfield
country: United States
facility: Sacred Heart Medical Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Brackenridge Hospital/Seton Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: Neurological Associates/CJW Med Ctr
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Virginia Beach General Hospital
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Linz
country: Austria
facility: AKH General Hospital
city: Salzburg
country: Austria
facility: Christian-Doppler-Klinik
city: Tulln
country: Austria
facility: Donauklinikum Tulln
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ St Jan Brugge
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Cologne
country: Germany
facility: Klinikum Köln-Merheim
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Essen
country: Germany
facility: Universitatsklinikum Duisberg-Essen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Kliniken
city: Debrecen
country: Hungary
facility: Medical Health and Science Center, University Of Debrecen
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Bern
country: Switzerland
facility: InselSpital
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: University of Alberta, Edmonton
name: Ashfaq Shuaib, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.