Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator "FASTFlo tPA"

Completed

Phase 1 Results N/A

Trial Description

To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.

Conditions

Interventions

  • NeuroFlo catheter Device
    Intervention Desc: NeuroFlo™ catheter 45 minute treatment
    ARM 1: Kind: Experimental
    Label: NeuroFlo Treatment

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment. Baseline to 30 days post-treatment Yes
Secondary Potential patient benefit will be assessed through collection of neurological indices. Baseline through 90 days No

Sponsors