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

Completed

Phase 3 Results N/A

Trial Description

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

Interventions

  • Catheter (NeuroFlo catheter)Other
    Intervention Desc: NeuroFlo catheter
  • Control Device
    Intervention Desc: ASA Guidelines
    ARM 1: Kind: Experimental
    Label: 2
  • NeuroFlo™ catheter Device
    Intervention Desc: 45 minute treatment
    ARM 1: Kind: Experimental
    Label: 1

Trial Design

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

Patient Involvement

Participation in the study will last 90 days and involve 2 follow-up visits. Procedures include physical exams, lab work, neurological exams, CT/MR imaging, ECG. The treatment group will also receive an aortogram and NeuroFlo therapy.

Outcomes

Type Measure Time Frame Safety Issue
Primary Efficacy as measured by neurological improvement; and safety as measured by serious adverse events at 90 days.
Secondary Acute improvement in neurological function 24 hours post-procedure, and comparison of SIS at 30 &amp; 90 days, hospital length of stay, and patient disposition upon discharge.
Primary The safety of the NeuroFlo device and procedure will be compared to medical management alone 90 days Yes
Primary Efficacy will be assessed using a global outcome score 90 days No
Secondary Acute improvement in neurological function 24 hours No
Secondary Stroke Impact Scale 30 & 90 days No
Secondary Hospital length of stay Varies No
Secondary Patient disposition upon discharge will be compared Varies No

Sponsors