Overlook Medical Center’s Atlantic Neuroscience Institute is set to participate in the MIND trial: a prospective, multicentre, randomised controlled trial (RCT) examining the Artemis Neuro Evacuation Device (Penumbra), a minimally invasive device used to remove intracerebral haemorrhage.
The study is designed to compare the safety and efficacy of the Artemis Neuro Evacuation Device to best medical management in evacuating intracerebral haemorrhage in eligible patients. Paul Saphier, serves as the lead investigator for the local arm of the study. Saphier is an endovascular neurosurgeon at Overlook Medical Center’s Atlantic Neuroscience Institute.
“Our interventionalist team has performed approximately 100 of these procedures using the Artemis device and Penumbra’s prior generation device over a two-year period,” according to Saphier. “We are proud to be a major participant in this trial, as well as many others, that provide a benefit to our patients.”
According to a press release, the Artemis device is inserted with the endoscope into a small incision to the affected area of the brain. The Artemis device removes the clot through its cannula using suction, powered by a proprietary external vacuum source. The team at Overlook Medical Center is trained to use the device in conjunction with other equipment in the operating room, such as navigation, endoscope, and other devices.
In order to be included in the trial, patients must be 18–80 years old with an intracerebral haemorrhage. Patients will be randomised (2:1) to receive either medical management with the Artemis device or medical management alone. Twice as many patients will receive medical management with the Artemis device.
The primary outcome measures include global disability (functional outcome), which will be assessed via the ordinal modified Rankin Scale (mRS) score, and rate of mortality within 30 days. At present, the estimated primary completion date is July 2022, while the estimated study completion date is July 2023.