An acronym standing for Early MiNimally-invasive Removal of ICH, ENRICH is a randomized, multicenter, adaptive clinical trial led by Emory University and Grady Memorial Hospital and sponsored by NICO Corporation. The post market trial compares standard medical management to early (<24 hours), minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial ICH.
The purpose of the trial stands to provide clinical evidence of functional improvement, safety, and economic benefit, measured by various endpoints, when comparing early surgical evacuation to the standard of care medical management for ICH. Patients are randomized to receive either ICH surgical evacuation using the NICO Myriad and BrainPath devices or standard medical treatment.
Safety will be assessed by determining procedure-related morbidity and mortality through demonstrating that early surgery does not result in increased procedure related mortality or rebleeding when comparing with medically managed patients at 30-days.
Clinical efficacy will be measured primarily using standard stroke disability scales by demonstrating that MIPS results in a 10% improvement in utility weighted modified Rankin Scale (uwmRS) at 180-days.
Secondary Endpoints for Efficacy
- Assessment and quantification of post-operative complications and post-operative rebleeding following parafascicular ICH evacuation with atraumatic access to the hematoma
- Demonstration of the relationship between reduction in percent ICH from the minimally invasive approach and functional outcomes as determined by the uwmRS
- Evaluation of impact from minimally invasive surgery on ICU LOS, as well as overall in-hospital LOS as compared to medically treated patients (to include estimated cost comparison among groups)
- Comparison of uwmRS at discharge, 30-days and 90-days