Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients "Flo 24"

Completed

Phase 1 Results N/A

Trial Description

The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. 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, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours.
A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian & European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.

Conditions

Interventions

  • Catheter (NeuroFlo catheter)Other
    Intervention Desc: NeuroFlo catheter
  • NeuroFlo™ catheter Device
    Intervention Desc: 45 minute Treatment
    ARM 1: Kind: Experimental
    Label: 1

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Patient Involvement

Patients will be treated with the NeuroFlo catheter. Participation in the study will last 90 days and involve two follow-up visits.

Outcomes

Type Measure Time Frame Safety Issue
Primary All adverse events occurring from baseline to 30 days post treatment.
Secondary Change in stroke severity on neurological indices (NIHSS, etc.) at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days. Tissue perfusion changes associated with device therapy to be assessed utilizing MRI perfusion studies acquired at baseline and ? 4 hours post-procedure. Safety will be assessed by an independent data and safety monitoring board.
Primary Assessment of all adverse events from baseline to 30 days post-treatment. 30 Days Yes
Secondary Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days. 90 Days No
Secondary Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure. ≤ 4 hours No

Sponsors