The ENRICH (Early MiNimally-invasive Removal of ICH) randomized clinical trial launched in January this year, designed to compare the outcomes between early intervention of clot removal using the BrainPath Approach™ and the medical management standard of care, has doubled its trial site number due to growing interest in participation. The trial originally included up to 15 sites; more than 70 applications have been received requesting participation, leading site sponsors to approve increasing the
number of sites.
ENRICH is a multi-center trial sponsored by NICO Corporation and led by the Emory Stroke Center of Emory University hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital. The 300-patient trial is unique in that the multi-disciplinary teams of stroke neurology, neurosurgery and neuro-critical care physicians are participating at each trial site. Ideal trial candidates are spontaneous supratentorial ICH patients with a good clinical chance of benefiting from the surgical treatment based on well-defined criteria for study enrollment.
The BrainPath Approach uses a combination of technologies, including the patented and FDA-cleared NICO BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot evacuation. BrainPath is the only technology in the world designed for trans-sulcal access into the brain by navigating through the delicate folds and fiber tracts of the brain, displacing brain tissue as it creates a corridor to the hemorrhage site about the size of a dime. Clot evacuation occurs using the Myriad. More than 500
neurosurgeons, residents and fellows have been trained on BrainPath and more than 6,000 procedures have been completed throughout the United States, Canada, the United Kingdom and Australia.
Hemorrhagic stroke (ICH) is the deadliest, costliest and most debilitating form of stroke that impacts more than 160,000 people in the U.S. and 3.4 million people worldwide. It is considered the deadliest kind of stroke due to blood accumulation in the brain after the rupture, which causes mass effect and toxicity – leaving a grim clinical outcome for the patient and an early mortality rate of 32-50 percent.
The current standard of care for ICH calls for medical management of the patient, or a “watch and see” protocol, which allows blood that is pooled from the ruptured vessel and toxic to remain in the brain. The ENRICH trial goal is to compare the efficacy and safety of standard medical management of ICH to early surgical evacuation (less than 24 hours) using a parafascicular (parallel to the brain’s fiber tracts) and transsulcal (natural openings and folds of the brain) surgical approach. The goal of surgical evacuation is to maximize clot removal, achieve durable hemostasis, and achieve functional improvement of the patient.
For more information about the ENRICH trial and to learn more about patient criteria for the trial, visit www.ENRICHtrial.com.