CoAxia is conducting a pivotal trial to demonstrate the safety and efficacy of its NeuroFlo cathether as a treatment for ischemic stroke. The trial, SENTIS (Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke) is being conducted at leading stroke centers in North America and Europe. The trial will determine if this unique method for increasing blood flow to the brain (with a catheter partially occluding the aorta) can minimize the damage caused by stroke and improve patient outcome in patients up to 14 hours after the onset of their stroke.
The study is a prospective, controlled, randomized, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution for stroke severity and duration. The primary efficacy endpoint is 90 day neurological and functional status. Additional endpoints include safety, perfusion enhancement, 24 hour neurological status, and quality of life.
Eligible subjects are men and women over the age of 18 with symptoms of an ischemic stroke. NIHSS neurological status score must be between 5-18 and time from symptom onset less than 14 hours. A maximum of 244 patients may be enrolled in each study arm.
Patient enrollment began in early 2006 and will continue through 2009. Over 70 sites have committed to participate in the trial and over 225 patients have been enrolled to date. Any clinical sites interested in participating should contact us.
CoAxia, in conjunction with several leading stroke centers, has co-authored an additional protocol to test the feasibility of treating patients with the NeuroFlo catheter out to 24 hours after the onset of a stroke, potentially making this an option for victims who suffer their stroke while sleeping or otherwise do not seek treatment for several hours. This study, called Flo24, is designed to be a safety / feasibility study to assess the safety of treating late presenting stroke patients who demonstrate an ischemic penumbra in an MRI perfusion scan. This feasbility study has concluded and the results are being prepared for publication.
CoAxia is also evaluating the initial safety and feasibility of using NeuroFlo as an adjunct to IV tPA. This small feasibility trial, FASTFlo, is nearly complete and plans for a longer randomized study are in progress.
CoAxia is constantly evaluating new concepts for stroke treatment using its unique approach to cerebral perfusion augmentation. As such, new research and studies are being evaluated with its collaborators and partners. If you have ideas for additional or complementary evaluations of NeuroFlo technology, please contact us.
CoAxia is also conducting a study of the economic impact and benefits of its NeuroFlo treatment. The Study of Care Intensity and Outcomes of NeuroFlo (SCION) trial will be conducted in conjunction with SENTIS. Most subjects enrolled in SENTIS will also participate in SCION. The purpose of SCION is to provide data for an economic analysis of the NeuroFlo stroke therapy. The objective of the study is to compare patients with and without NeuroFlo therapy relative to how they move through the health care system in the post-acute period, utilize health care resources and regain their quality of life.
In 2005, CoAxia received FDA approval for the NeuroFlo Catheter to treat patients with cerebral vasospasm under a Humanitarian Device Exemption. The Model 1017 NeuroFlo catheter is approved for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage (SAH), secured by either surgical or endovascular intervention for patients who have failed maximal medical management.
Data on vasospasm patients treated with the NeuroFlo catheter demonstrated a complication rate consistent with this severely ill population as well as indications of potential benefit via 50% of patients showing an acute neurological improvement of 4 points or greater in the NIHSS scale.
Along with this recent US release of the HDE-approved catheter, CoAxia is making available a patient data and outcomes registry. The objectives of the registry are to gather data demonstrating perfusion augmentation in symptomatic vasospasm patients treated with NeuroFlo, and to gather data regarding clinical outcome.
Centers that may be interested in adding this unique treatment to the management of their subarachnoid hemorrhage population and/or participating in the CoAxia registry should contact us.
In addition to stroke, planning is ongoing for clinical feasibility studies to evaluate the potential of CoAxia’s perfusion augmentation technology for other cerebral, cardiac and renal applications.
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