Imperative Care has announced that the first patient has been enrolled in the Imperative trial. This prospective, multicentre clinical trial is the first study designed to evaluate the clinical benefits of direct aspiration for the treatment of ischaemic stroke with the Zoom 88 Large Distal Platform—which is currently US Food and Drug Administration (FDA)-cleared for neurovascular access.
Additionally, the trial will gather data on the clinical benefits of the full Zoom Stroke Solution, the company’s ischaemic stroke product portfolio that includes the Zoom 88 Large Distal Platform for neurovascular access, four Zoom aspiration catheters in various sizes, and a pump with accessories.
“This is a historical trial, which is evaluating what I consider to be the biggest breakthrough in endovascular stroke treatment since the advent of stent retrievers over a decade ago,” said Raul Nogueira, professor of Neurology and Radiology at Emory University School of Medicine (Atlanta, USA) and principal investigator of the Imperative trial. “The 0.088-inch large bore intracranial aspiration catheter technology may represent a paradigm shift of our first-line stroke technique strategy with the potential for full flow control, higher suction force, and complete clot ingestion.”
The first case in the Imperative trial was performed by Maxim Mokin, associate professor of Neurology and Neurosurgery at Tampa General Hospital affiliated with the University of South Florida (Tampa, USA). “I am thrilled to have successfully treated the first patient in this study with the Zoom 88,” said Mokin. “This trial will help neurointerventionists better understand the impact of large bore aspiration, particularly in regard to first pass effect and procedure time.”
Designed as a multispeciality study, the Imperative trial will enrol 262 patients at up to 30 sites in the USA and includes investigators from several specialities trained to treat ischaemic stroke—including neurosurgery, interventional radiology, and interventional neurology. Nogueira is joined by two additional investigators, William Mack, professor of Neurological Surgery and director of the Neurointerventional Program at Keck School of Medicine in the University of Southern California (Los Angeles, USA), and Reade De Leacy, associate professor of Neurosurgery and Radiology at Mount Sinai (New York, USA).
“At Imperative Care, the concept of elevating stroke care does not end with innovative technology,” said Daniel Davis, president and COO of Imperative Care. “We know that clinical data are foundational to validating technology and ensuring better patient care. We hope that this landmark study will position direct aspiration with the Zoom 88 to become another tool that enables physicians to effectively and expeditiously treat people suffering from a stroke.”
Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found here. In a press release, Imperative Care cautions that the Zoom 88 Large Distal Platform is not cleared for aspiration, and is an investigational device when used for aspiration, limited by federal (or US) law to investigational use.