Stryker halts Trevo Retriever study enrolment early due to likely success

Stryker announced Wednesday that it will end enrolment early in a trial designed to compare mechanical thrombectomy with the company's Trevo Retriever plus medical therapy against medical therapy alone when initiated in stroke patients within six hours to 24 hours after time last known well. Stryker noted that it took the decision due to the "high probability" of success of the DAWN trial.

The study was designed to enrol up to 500 patients and set out to demonstrate superior clinical outcomes at 90 days with the Trevo Retriever plus medical management. According to Stryker, the study's independent Data Safety Monitoring Board "recommended stopping study enrolment based on a pre-planned interim review of data from the first 200 patients," which concluded that multiple pre-specified stopping criteria were met. The company indicated that it will conduct a final analysis of the data upon completion of the remaining patient follow-up, adding that the trial's outcomes "may represent a major change in patient selection for endovascular therapy for stroke."

Raul Nogueira, co-principal investigator, said that "if the final results...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."

In 2012, the device was cleared by the FDA for the revascularisation of patients experiencing ischaemic stroke, while the next generation Trevo ProVue Retriever was launched later that year. In 2016, the FDA announced the clearance of Stryker's two Trevo clot retrieval devices as an initial therapy for ischaemic strokes to "reduce paralysis, speech difficulties and other stroke disabilities."

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