The ENRICH (Early MiNimally-invasive Removal of ICH) trial was designed to evaluate minimally invasive parafascicular surgery (MIPS) and intracerebral hemorrhage (ICH) removal using NICO’s complete technology solution, BrainPath® and Myriad® versus medical management, as defined by the American Heart Association/American Stroke Association guidelines. ENRICH met its primary endpoint demonstrating MIPS using BrainPath and Myriad improved functional outcomes versus medical management alone. The initial results were presented at a leading medical congress on April 22.
The primary intention-to-treat analysis evaluated whether the utility-weighted modified Rankin Scale (UWmRS), a standardized measure of global disability, at 180 days in the treatment group was superior to that of the control group. The secondary safety endpoints were mortality at 30 days, change in hemorrhage volume between index and 24-hour CT scan. The trial also evaluated secondary economic endpoints, which are quality-adjusted life years (QALY) at 90-, 120- and 180-days post hemorrhage. The full ENRICH results will be published in 1H and the economic results will be available in 2H.
The ENRICH trial is a randomized, multi-center, adaptive, clinical trial designed to evaluate the effectiveness, safety and economics of a standardized early MIPS approach in 300 people with spontaneous ICH. The trial enrolled patients at 37 stroke centers across the U.S.
ENRICH is the culmination of seven years of intense work and, ultimately, the delivery of the NICO mission to improve outcomes in ICH. We thank the entire stroke community for their efforts in supporting the ENRICH trial, especially our partner, Emory University, the ENRICH investigators, stroke centers and coordinators, patients and caregivers for helping to deliver this groundbreaking science.
Read the related Press Release