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Completed

NCT Number: NCT00119717

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

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.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AKH General Hospital, Linz, Austria

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About this study

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:

  • National Institute of Health Stroke Scale (NIHSS) at baseline (stratify <10, 11-18)
  • Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify <5 hrs, or ≥5 hrs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroFlo™ Catheter

Device

45 minute treatment

Control

Other

ASA Guidelines

Primary outcomes

  1. The safety of the NeuroFlo device and procedure will be compared to medical management alone

    Time frame: 90 days

  2. Efficacy will be assessed using a global outcome score

    Time frame: 90 days

Secondary outcomes

  1. Acute improvement in neurological function

    Time frame: 24 hours

  2. Stroke Impact Scale

    Time frame: 30 & 90 days

  3. Hospital length of stay

    Time frame: Varies

  4. Patient disposition upon discharge will be compared

    Time frame: Varies

Sponsors and collaborators

Lead sponsor

CoAxia

Industry

Registry information

Acronym: SENTIS

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jul 14, 2005
Registry last updated
May 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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