More than 100 subjects are now enrolled in the ENRICH randomized controlled trial designed to compare the outcomes between early surgical intervention of clot removal using the minimally disruptive BrainPathâ Approach (NICO Corporation) and the “watch and see” medical management standard of care. ENRICH (Early MiNimally-invasive Removal of ICH) opened patient enrollment in January 2017 for the 300-patient trial that uniquely includes multi-disciplinary teams of stroke neurology, neurosurgery and neuro-critical care physicians from each of the 30 trial sites that include major medical and academic centers and large community hospitals. Nearly 100 site surveys were received from interested sites to participate in the trial.
ENRICH is a multi-center trial sponsored by NICO and led by the Emory Stroke Center of Emory University hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital, both in Atlanta. Ideal trial subjects are spontaneous supratentorial intracerebral hemorrhage (ICH) patients with a potential chance of benefiting from surgical treatment based on well-defined criteria for study enrollment.
“Our goal in funding this important trial is to find an effective treatment for appropriate patients with ICH – the deadliest, costliest and most debilitating form of stroke that currently has no surgical solution,” said Jim Pearson, president and CEO of NICO Corporation. “The BrainPath Approach allows surgeons to access the blood clot early and remove the maximum amount possible. As we end Stroke Awareness Month today, it’s important to recognize this trial milestone. We believe the trial will show that taking the steps of early intervention and maximal clot removal can contribute to improved clinical and functional outcomes for patients.”
The current standard of care for ICH calls for medical management of the patient that often allows blood to remain in the brain, causing mass effect and toxicity that triggers a grim clinical outcome for the patient and early mortality rates of 32-50 percent. The ENRICH goal is to compare the efficacy and safety of standard medical management of ICH to early surgical evacuation (less than 24 hours) using the BrainPath Approach, a parafascicular (parallel to the brain’s fiber tracts) and trans-sulcal (natural openings and folds of the brain) surgical approach that can result in maximum clot removal, durable hemostasis, and functional improvement of the patient. The BrainPath Approach uses the NICO BrainPath for minimally-disruptive access and automated NICO Myriadâ for clot evacuation.
Hemorrhagic stroke impacts more than 160,000 people in the U.S. and 3.4 million people worldwide. Caused from a weakened vessel that ruptures and bleeds into surrounding brain, previous studies suggest early removal of the hemorrhage can potentially mitigate brain injury; however, procedures in these studies did not offer automated, navigation-compatible, minimally-disruptive technologies and a standardized surgical approach. For more information about the ENRICH trial or patient criteria, visit ClinicalTrials.gov or EnrichTrial.com.