Trial of Minimally Invasive Parafascicular Surgery for Hemorrhagic Stroke Completes Enrollment

The ENRICH multicenter randomized controlled trial (NCT02880878) has completed enrollment and will evaluate minimally invasive parafascicular surgery (MIPS) to treat intracerebral hemorrhage (ICH). The trial will have an adaptive enrollment design  based on ICH location to increase the chance of therapeutic benefit. The ENRICH trial is the first clinical trial to use trans-sulcal folds to access and surgically address hemorrhages within 24 hours of identification.

In May 2022, The American Heart Association-American Stroke Association updated the treatment guidelines for ICH to include minimally invasive surgery approaches (eg, MIPS.

“Historically, supratentorial intracerebral hemorrhage 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 Dr. Gustavo Pradilla of Emory University, coprincipal investigator of the ENRICH trial.

After a 180-day participant follow-up period, results will be announced, which is anticipated for the first quarter of 2023.

 “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 chief executive officer of NICO Corporation, sponsor of the ENRICH trial. “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.”