Clinical Trials Logo
  1. Home
  2. Cerebrovascular Accident
  3. NCT00119717

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
See also
  Status Clinical Trial Phase
Completed NCT05477238 - Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls N/A
Completed NCT00046293 - ReoPro and Retavase to Treat Acute Stroke Phase 2
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT01116544 - Treatment of Chronic Stroke With AMES + EMG Biofeedback N/A
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Active, not recruiting NCT02563886 - Electrically Assisted Movement Therapy N/A
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT02141932 - Pocket-size Cardiovascular Ultrasound in Stroke N/A
Completed NCT01915368 - Determining Optimal Post-Stroke Exercise (DOSE) N/A
Recruiting NCT02557737 - Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities Phase 3
Recruiting NCT01769326 - Influence of Timing on Motor Learning N/A
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Completed NCT01423201 - Transient Ischemic Attack (TIA) Triage and Evaluation of Stroke Risk
Completed NCT01656876 - The Effects of Mirror Therapy on Upper Extremity in Stroke Patients N/A
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT00542256 - tDCS and Physical Therapy in Stroke N/A
Withdrawn NCT00573092 - Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs N/A
Completed NCT00377689 - Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke Phase 2
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Terminated NCT00120289 - Niacin Plus Statin to Prevent Vascular Events Phase 3