Cerevasc has announced it has completed patient enrolment in its STRIDE pivotal trial evaluating the investigational eShunt system in patients with normal-pressure hydrocephalus (NPH).
With patient enrolment complete at 32 clinical sites, STRIDE is progressing through remaining treatment and follow-up activities for consented patients, keeping the company on track toward topline data and continued progress through the US Food and Drug Administration (FDA) premarket approval (PMA) process, as stated in a press release.
STRIDE is a prospective, multicentre randomised controlled trial comparing the eShunt system head-to-head against the current standard of care—the ventriculoperitoneal (VP) shunt—in elderly patients with NPH. The results are intended to serve as the clinical basis for Cerevasc’s anticipated PMA submission to the US FDA.
According to Cerevasc, the investigational eShunt system is the only endovascular shunt in clinical use and the first new treatment option developed for NPH since the standard of care was introduced more than 60 years ago. The current standard-of-care treatment is brain surgery to place a conventional shunt. Some older patients, particularly those with comorbidities, may not be considered suitable candidates for conventional shunt surgery, potentially leaving them untreated.
“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 Dan Levangie, chairman and chief executive officer (CEO) of Cerevasc. “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.”
“Reaching full enrolment is an important achievement for STRIDE and reflects the clinical community’s commitment to studying less invasive treatment options for patients with NPH,” added Charles Matouk (Yale New Haven Hospital, New Haven, USA). “The study will continue to follow its protocol as previously consented patients complete the remaining clinical steps.”
