NCT00119717

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 515 (actual)
• Sponsor: CoAxia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	NeuroFlo™ catheter	45 minute treatment
OTHER	Control	ASA Guidelines

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2005-07-14
• Last updated: 2011-05-18

Locations

72 sites across 10 countries: United States, Austria, Belgium, Canada, Germany, Hungary, Israel, Puerto Rico, Spain, Switzerland