Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) - Full Text View

Purpose

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	Intervention	Phase
Cerebrovascular Accident	Device: NeuroFlo™ catheter Other: Control	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

Further study details as provided by CoAxia:

Primary Outcome Measures:

The safety of the NeuroFlo device and procedure will be compared to medical management alone [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Efficacy will be assessed using a global outcome score [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute improvement in neurological function [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Stroke Impact Scale [ Time Frame: 30 & 90 days ] [ Designated as safety issue: No ]
Hospital length of stay [ Time Frame: Varies ] [ Designated as safety issue: No ]
Patient disposition upon discharge will be compared [ Time Frame: Varies ] [ Designated as safety issue: No ]

Enrollment:	515
Study Start Date:	June 2005
Study Completion Date:	July 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Device: NeuroFlo™ catheter 45 minute treatment
Active Comparator: 2	Other: Control ASA Guidelines

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119717

Show 72 Study Locations

Sponsors and Collaborators

CoAxia

Investigators

Principal Investigator:

Ashfaq Shuaib, MD

University of Alberta, Edmonton

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Shuaib A, Bornstein NM, Diener HC, Dillon W, Fisher M, Hammer MD, Molina CA, Rutledge JN, Saver JL, Schellinger PD, Shownkeen H; for the SENTIS Trial Investigators. Partial Aortic Occlusion for Cerebral Perfusion Augmentation: Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke Trial. Stroke. 2011 May 12; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:i21-4. doi: 10.1136/neurintsurg-2012-010562. Epub 2013 Jan 3.

Responsible Party:	Ashfaq Shuaib, MD, University of Alberta, Edmonton
ClinicalTrials.gov Identifier:	NCT00119717 History of Changes
Other Study ID Numbers:	CD-0125
Study First Received:	July 7, 2005
Last Updated:	May 16, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Israel: Ministry of Health

Keywords provided by CoAxia:

acute
ischemic
stroke

randomized
device
treatment

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013