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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
45 minute Treatment
UCLA
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Assessment of all adverse events from baseline to 30 days post-treatment.
Time frame: 30 Days
Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.
Time frame: 90 Days
Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.
Time frame: ≤ 4 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chapel Hill, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Erlangen
Erlangen, Germany
University of Essen
Essen, Germany
CHUV Lausanne
Lausanne, Switzerland