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

Phase 3

Completed

• Conditions: Cerebrovascular Accident

• Registration Number: NCT00119717
• Lead Sponsor: CoAxia

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).

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-07-07
• Study First Submitted QC: 2005-07-07
• Study First Posted: 2005-07-14
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (72)

Huntsville Hospital; 🇺🇸 Huntsville, Alabama, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Good Samaritan Hospital; 🇺🇸 San Jose, California, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

University of Florida; 🇺🇸 Jacksonville, Florida, United States

Univ. of Miami; 🇺🇸 Miami, Florida, United States

Munroe Regional Medical Center; 🇺🇸 Ocala, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

The Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

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