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

Cerebrovascular Accident Clinical Trial

— SENTIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119717
• Other study ID #: CD-0125
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2005
• Last updated: May 16, 2011
• Start date: June 2005
• Est. completion date: July 2010

Study information

• Verified date: May 2011
• Source: CoAxia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIsrael: Ministry of Health
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• NeuroFlo™ catheter
45 minute treatment

Other:
• Control
ASA Guidelines

Locations

Country	Name	City	State
Austria	AKH General Hospital	Linz
Austria	Christian-Doppler-Klinik	Salzburg
Austria	Donauklinikum Tulln	Tulln
Belgium	ZNA Middelheim	Antwerpen
Belgium	AZ St Jan Brugge	Brugge
Belgium	UZ Gasthuisberg	Leuven
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	University of Western Ontario	London	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Germany	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
Hungary	Medical Health and Science Center, University Of Debrecen	Debrecen
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Hebrew University	Jerusalem
Israel	Sourasky Medical Center	Tel Aviv
Israel	Chaim Sheba Medical Center	Tel Hashomer
Puerto Rico	University of Puerto Rico	San Juan
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Switzerland	InselSpital	Bern
Switzerland	CHUV	Lausanne
United States	Albany Medical Center	Albany	New York
United States	Brackenridge Hospital/Seton Medical Center	Austin	Texas
United States	Maimonides Medical Center	Brooklyn	New York
United States	Univeristy of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	JFK Medical Center	Edison	New Jersey
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Methodist Hospital	Houston	Texas
United States	Huntsville Hospital	Huntsville	Alabama
United States	University of Florida	Jacksonville	Florida
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Michigan State University	Lansing	Michigan
United States	Sunrise Medical Center	Las Vegas	Nevada
United States	Central Baptist Hospital	Lexington	Kentucky
United States	UCLA	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Univ. of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	St. Joseph Mercy - Oakland	Pontiac	Michigan
United States	Neurological Associates/CJW Med Ctr	Richmond	Virginia
United States	Rochester General Hospital	Rochester	New York
United States	University of Rochester	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Good Samaritan Hospital	San Jose	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Swedish Medical Center	Seattle	Washington
United States	Providence Hospital	Southfield	Michigan
United States	Sacred Heart Medical Center	Springfield	Oregon
United States	St. Louis University	St. Louis	Missouri
United States	Washington University	St. Louis	Missouri
United States	SUNY-Upstate Medical Univ.	Syracuse	New York
United States	Sentara Virginia Beach General Hospital	Virginia Beach	Virginia
United States	Winchester Medical Center	Winchester	Virginia
United States	Central DuPage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
CoAxia

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,  Hungary,  Israel,  Puerto Rico,  Spain,  Switzerland, 

References & Publications (1)

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 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of the NeuroFlo device and procedure will be compared to medical management alone		90 days	Yes
Primary	Efficacy will be assessed using a global outcome score		90 days	No
Secondary	Acute improvement in neurological function		24 hours	No
Secondary	Stroke Impact Scale		30 & 90 days	No
Secondary	Hospital length of stay		Varies	No
Secondary	Patient disposition upon discharge will be compared		Varies	No

External Links

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