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

Sponsored by:	CoAxia
Information provided by:	CoAxia
ClinicalTrials.gov Identifier:	NCT00119717

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	500
Study Start Date:	June 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

Contacts

Contact: CoAxia

763-315-1809

Show 70 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

No publications provided

Responsible Party:	University of Alberta, Edmonton ( Ashfaq Shuaib, MD )
Study ID Numbers:	CD-0125
Study First Received:	July 7, 2005
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00119717 History of Changes
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

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009