Stryker (NYSE:SYK) said today that it’s putting an early stop to enrollment in a clinical trial of its Trevo anti-stroke device after a review board decided there’s a high probability of success for the study.
Kalamazoo, Mich.-based Stryker paid $135 million for Concentric Medical and its Trevo clot retriever back in 2011. The device is designed to remove the blood clots that cause ischemic stroke. Stryker said it’s halting enrollment in the 500-patient Dawn trial after signing on just 200 patients after a scheduled review by the study’s independent Data Safety Monitoring Board.
The Dawn trial is comparing treatment using the Trevo thrombectomy device plus clot-busting drugs with the drugs alone between 6 and 24 hours after the patient was last known to be well. Stryker said the DSMB’s interim review of the 1st 200 patients, designed to assess for efficacy, showed that “multiple pre-specified stopping criteria were met.” The final data analysis is due once follow-up is complete on the already-enrolled patients, the company said.
“Treating acute stroke patients with large vessel occlusion who present later than 6 hours from last seen well has the potential to help thousands of stroke patients around the world,” co-principal investigator Dr. Tudor Jovin, of the University of Pittsburgh Medical Center, said in prepared remarks. “These patients, many of whom present to the hospital outside of the 6-hour time window, could have a better chance for an independent life with improved clinical outcomes.”
“If the final results of the Dawn trial are positive, it will provide physicians who treat stroke with evidence of the benefits of thrombectomy even when administered out as far as 24 hours, and should help to make decisions clearer as to which patients to treat,” added co-principal investigator Dr. Raul Nogueira of the Grady Memorial Hospital/Emory University.