CoAxia Announces Results of SENTIS Ischemic Stroke Trial
Positive signals of safety & efficacy presented at World Stroke Congress
Minneapolis, MN, October 18, 2010
CoAxia Inc. of Maple Grove, MN, announced today that the results of the SENTIS clinical trial - a worldwide, multi-center, randomized study of its NeuroFlo™ catheter – were presented on Saturday, October 16th, by SENTIS Principal Investigator, Professor Ashfaq Shuaib at the 2010 World Stroke Congress in Seoul, South Korea. Professor Shuaib noted that SENTIS is the first randomized trial of an acute interventional treatment in ischemic stroke patients to signal safety and long term improvement in clinical outcomes. CoAxia is developing plans to submit trial results to the US FDA and exploring options to initiate marketing of the NeuroFlo technology in Europe, where it has previously received CE Mark.
Professor Shuaib, Director of Stroke Services, University of Edmonton Medical Center, described the SENTIS trial results as follows: whereas the NeuroFlo treatment did not achieve statistical significance in its primary efficacy measure, it did achieve the trial’s primary safety endpoint and demonstrated numerous positive indications of both safety and benefit. He presented positive safety results in overall mortality and stroke-related mortality, and improved neurological outcomes, as measured by 90 day modified Rankin 0-2 scores, in early-presenting patients, mid-range stroke patients, and patients over 70 years of age.
The SENTIS trial included patients presenting with strokes up to 14 hours after symptom onset with baseline stroke severity NIHSS scores between 5 and 18. Patients were randomized 1:1 to either NeuroFlo treatment or standard medical care. Patients eligible for either intra-venous tPA (approximately 2-3% of stoke patients) or intra-arterial clot removal (< 1% of stroke patients) were excluded from the trial. The SENTIS endpoints included a range of neurological efficacy and safety measures assessed 90 days after symptom onset. These measures included the primary efficacy endpoint of a Return to Normal Neurological Status based on the NINDS Global Score, and secondary efficacy measures of Modified Rankin Scores (mRS 0-2 and Rankin Shift). Safety outcomes included the primary measure of total Serious Adverse Events and additional measures including Mortality and Symptomatic Intracranial Hemorrhage.
A summary of trial results (based on odds ratio comparisons of treatment and control groups) follows:
Secondary/Additional Efficacy Endpoints using the Dichotomized Modified Rankin 0-2 Score:
Secondary/Additional Safety Endpoints:
Professor Shuaib commented, “SENTIS is the first trial of an interventional device treatment which signals a long term patient benefit and strong safety in such a diverse patient group – one which is representative of the stroke patients we clinicians see every day. I believe that the NeuroFlo technology represents a significant step forward in stroke treatment – especially for the many stroke patients who have no treatment options today.”