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.
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.
- Catheter (NeuroFlo catheter)Other
Intervention Desc: NeuroFlo catheter
- NeuroFlo™ catheter Device
Intervention Desc: 45 minute Treatment ARM 1: Kind: Experimental Label: 1
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety Study
- Intervention: Single Group Assignment
Patients will be treated with the NeuroFlo catheter. Participation in the study will last 90 days and involve two follow-up visits.
|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|
- CoAxia Lead