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

Cerebrovascular Accident Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00119717
Study type Interventional
Source CoAxia
Contact
Status Completed
Phase Phase 3
Start date June 2005
Completion date July 2010
View Details
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