CereVasc has completed patient enrollment in STRIDE, its pivotal trial of the investigational eShunt System for normal pressure hydrocephalus (NPH), across 32 sites in Argentina, Canada and the US. The randomized, controlled study compares the eShunt with the standard ventriculoperitoneal (VP) shunt and is intended to provide data for a planned PMA submission to the US FDA. Remaining treatment and follow‑up are expected to finish by the end of July, with topline results to follow; the company also raised $85 million in Series C funding to support development.
CereVasc Completes Enrollment in STRIDE Pivotal Trial of eShunt for NPH
The trial will compare the eShunt System directly with the current standard treatment. Credit: RusAKphoto / Shutterstock.com.(RusAKphoto / Shutterstock.com.)
CereVasc announced that it has completed patient enrollment in STRIDE, the company’s pivotal clinical study evaluating the safety and effectiveness of the investigational eShunt System for normal pressure hydrocephalus (NPH).
Enrollment took place at 32 clinical sites, and the trial has advanced into the remaining treatment and follow‑up phases for patients who consented before enrollment closed. STRIDE is a multi‑centre, prospective, controlled and randomised study designed to compare the minimally invasive eShunt System directly with the current standard of care, the ventriculoperitoneal (VP) shunt, in elderly patients diagnosed with NPH.
Study Purpose and Regulatory Pathway
Outcomes from STRIDE are intended to form the clinical evidence base for a planned premarket approval (PMA) submission to the US Food and Drug Administration (FDA). The topline results are expected after the study’s primary endpoints have been reached and analysed.
Scope and Timeline
Recruitment was completed at sites in Argentina, Canada and the United States. Remaining treatment activities and follow‑up visits are scheduled to finish by the end of July, after which CereVasc expects to report topline findings once primary endpoint data are available.
Clinical Context
CereVasc notes that NPH affects an estimated 800,000 people in the United States and can lead to progressive motor impairment, cognitive decline and urinary incontinence. The condition is conventionally managed by brain surgery to implant a standard VP shunt; the eShunt is being developed as a less invasive alternative.
"Completing patient enrolment in STRIDE is the most important clinical milestone in CereVasc’s history and brings us closer to generating the data needed to support a PMA submission," said CereVasc chairman and CEO Dan Levangie. "We are grateful to the investigators, clinical site teams, patients, and CereVasc employees who have made this study possible. As consented patients complete the remaining treatment and follow‑up process, our focus remains on advancing a minimally invasive option for the hundreds of thousands of people living with NPH."
Funding
Earlier this month, CereVasc raised $85 million in a Series C financing round; the company said the funds will support continued development of the eShunt system and STRIDE study activities.
The STRIDE trial represents a key development milestone for CereVasc as it seeks to validate a new treatment option for NPH and pursue regulatory approval in the United States.
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