NICO Corporation has announced that enrolment is now complete for the ENRICH (Early minimally invasive removal of ICH) randomised controlled trial, which is comparing medical and economic outcomes between early surgical intervention for intracerebral haemorrhage (ICH) with minimally invasive parafascicular surgery (MIPS) to current guideline-directed medical management.
According to its sponsor, NICO, ENRICH is the first ICH trial using the natural folds of the brain (trans-sulcal) to access and surgically address haemorrhages within 24 hours of onset. It is also the first trial to adaptively enrol patients based on ICH location to maximise the likelihood of patient benefit, as per a press release from the company.
The MIPS approach utilised in ENRICH “uniquely integrates advanced imaging technologies with the NICO BrainPath for non-disruptive navigable access” using a parafascicular route to the ICH and NICO’s automated Myriad device “to pursue the goal of maximum clot evacuation”. The goal of this trans-sulcal approach is to allow surgeons to access and remove the haemorrhage more quickly—providing an opportunity for improved recovery—the release details.
“Historically, supratentorial ICH is a disease where all earlier surgical trials have failed to meet their primary endpoints. These studies, however, paved the way for future successes by providing specific metrics needed to impact functional outcomes,” said Gustavo Pradilla (Emory University, Atlanta, USA), co-principal investigator of the ENRICH trial.
The multicentre ENRICH trial is being led by the Emory Stroke Center of Emory University hospitals and Marcus Stroke & Neuroscience Center of Grady Memorial Hospital in Atlanta, USA. The trial leverages multidisciplinary teams, including stroke neurology, neurosurgery, and neurocritical care, at 33 sites that include major medical and academic centres, as well as large community hospitals, according to NICO.
The company has invested US$10 million and more than five years into the trial, which was initiated in January 2017. Results from ENRICH are expected to be announced in the first quarter of 2023 after the final 180-day patient follow-up period concludes.
In May this year, the American Heart Association-American Stroke Association (AHA-ASA) announced changes to existing stroke guidelines to include minimally invasive surgery approaches like MIPS when treating ICH.
“We are thrilled that ENRICH is now fully enrolled and want to express our sincere gratitude to all patients and healthcare providers involved in this groundbreaking adaptive trial,” said Jim Pearson, president and CEO of NICO. “We are hopeful the trial results will reinforce the recent changes to ICH guidelines and further define the role of MIPS in treating patients who suffer from ICH.”