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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00119717

Acronym

SENTIS

Enrollment

515

Registered

2005-07-14

Start date

2005-06-30

Completion date

2010-07-31

Last updated

2011-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

Keywords

acute, ischemic, stroke, randomized, device, 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).

Interventions

DEVICENeuroFlo™ catheter

45 minute treatment

OTHERControl

ASA Guidelines

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The safety of the NeuroFlo device and procedure will be compared to medical management alone	90 days
Efficacy will be assessed using a global outcome score	90 days

Secondary

Measure	Time frame
Acute improvement in neurological function	24 hours
Stroke Impact Scale	30 & 90 days
Hospital length of stay	Varies
Patient disposition upon discharge will be compared	Varies

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026