Enrollment Begins in Study on the Cognitive Benefits of Thrombectomy for Stroke Patients

Rapid Medical has enrolled the first patient in its COGNITIVE Study, the first to examine a link between mechanical thrombectomy and cognitive improvement. The trial will specifically evaluate the role of the company’s stent retriever in helping preserve cognitive function during ischemic stroke.

Rapid Medical’s TIGERTRIEVER—the only active stent retriever—may uniquely preserve cognitive function with a tailored approach to removing thrombus while limiting impact to the natural vessel. National Principal Investigator Dr. Fawaz Al-Mufti, M.D., of Westchester Medical Center in Westchester, N.Y., performed the procedure.

“This is a significant milestone for the neuro-interventional field,” Dr. Al-Mufti stated. “Up to 70% of stroke patients will experience cognitive impairment. While we know thrombectomy improves functional outcomes such as limb movement, we have yet to determine the impact on patients’ cognition. Because of TIGERTRIEVER, this study could re-examine how we treat patients.”

The TIGERTRIEVER Revascularization Device reportedly is the first active thrombectomy device that eliminates conventional thrombectomy’s trade-offs, and published data has proven its positive impact on patient outcomes. Different from leading conventional stent retrievers that self-expand to capture clots, TIGERTRIEVER enables physicians to adjust intra-arterially for vessel protection and tailored patient procedures. In a multicenter trial comparing seven pivotal stent retriever trials, TIGERTRIEVER presented faster procedure times, high first-pass revascularization, and good clinical outcomes.¹

“Rapid Medical plans to enroll up to 450 patients at 50 sites. Patients between the ages 18-75 who present with a large vessel occlusion (LVO) and are treated with TIGERTRIEVER for thrombus removal may be included,” Rapid Medical Chief Medical Officer Dr. Walid Haddad stated. “We’re proud to be at the forefront of this research and are honored to partner with clinical leaders like Dr. Al Mufti, who share the same commitment to advancing this space.”

Additional national principal investigators include Dr. Satoshi Tateshima, M.D. (UCLA, CA). The late Dr. Justin Singer was instrumental in the study’s design.

Rapid Medical is pioneering advanced interventional devices that treat ischemic and hemorrhagic stroke. Utilizing proprietary manufacturing techniques, the firm’s products are remotely adjustable and fully visible, enabling physicians to respond in real-time to the anatomy and tailor the approach to every patient for better procedural outcomes. TIGERTRIEVER 13, 17, and 21, COMANECI and COLUMBUS/DRIVEWIRE 14 are CE marked and cleared by the U.S. Food and Drug Administration (FDA). DRIVEWIRE 24 is also FDA-cleared. TIGERTRIEVER XL and 25 are CE marked.

Reference
¹ Gupta, Rishi et al. “New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial.” Stroke vol. 52,5 (2021): 1534-1544. doi:10.1161/STROKEAHA.121.034436