Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) (SENTIS)
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ClinicalTrials.gov Identifier: NCT00119717 |
Recruitment Status :
Completed
First Posted : July 14, 2005
Last Update Posted : May 18, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebrovascular Accident | Device: NeuroFlo™ catheter Other: Control | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 515 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Device: NeuroFlo™ catheter
45 minute treatment |
Active Comparator: 2 |
Other: Control
ASA Guidelines |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119717

Principal Investigator: | Ashfaq Shuaib, MD | University of Alberta, Edmonton |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ashfaq Shuaib, MD, University of Alberta, Edmonton |
ClinicalTrials.gov Identifier: | NCT00119717 |
Other Study ID Numbers: |
CD-0125 |
First Posted: | July 14, 2005 Key Record Dates |
Last Update Posted: | May 18, 2011 |
Last Verified: | May 2011 |
acute ischemic stroke |
randomized device treatment |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |