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

NCT00119717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2011-05-18

No results posted yet for this study

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.

Conditions

  • Cerebrovascular Accident

Interventions

DEVICE

NeuroFlo™ catheter

45 minute treatment

OTHER

Control

ASA Guidelines

Sponsors & Collaborators

  • CoAxia

    lead INDUSTRY

Principal Investigators

  • Ashfaq Shuaib, MD · University of Alberta, Edmonton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00119717 on ClinicalTrials.gov