Cerebrovascular Accident
Conditions
Keywords
acute, ischemic, stroke, device, treatment
Brief summary
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.
Interventions
DEVICENeuroFlo™ Catheter
45 minute Treatment
Sponsors
CoAxia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Ischemic stroke * NIHSS between 4-20 * Time from symptom onset between 8 and 24 hours
Exclusion criteria
* Hemorrhagic stroke * Certain types of heart disease * Kidney disease * Other conditions the doctor will assess
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of all adverse events from baseline to 30 days post-treatment. | 30 Days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure. | ≤ 4 hours |
Countries
Canada, Germany, Switzerland, United States
Outcome results
None listed