Stryker’s Wingspan StEnt System Post Market SurvEillance Study ( WEAVE Trial) as presented at the International Stroke Conference, testified the results for endovascular treatment with Wingspan Stent System for patients afflicted with intracranial atherosclerotic disease (ICAD) as the treatment set to alleviate the disease. WEAVE Trial is a multi-center, prospective, post-market surveillance study designed to assess the rate of stroke or death within 72 hours of the procedure in patients treated with the Wingspan Stent System.
Results signified patients receiving on-label treatment with the Wingspan Stent System demonstrated a 2.6% observed rate of stroke or death, compared to the pre-specified rate for early success, which was established as 4.0% with a minimum 150 patients. These results are significant when compared to the study’s null hypothesis with high predictive probability (>95%) that the true rate is 9.7%.
Dr. Michael Alexander, director of the Neurovascular Center at Cedars-Sinai in Los Angeles and principal investigator of the trial, noted, “These trial results have the potential to change how stroke patients are treated in the future. Using approved stents in the brain arteries may give new hope to patients suffering from a stroke due to blockages from cholesterol plaque.”
Investigators view the Trials as a crucial shift in the selection of patients for treatment by physicians. The results are commendable suggesting further development as compared to previous Trials confirming its approval and usage for treatment to assuage the disease. Work still needs to be done to ensure complete routing of the disease.
Mark-Paul, president of Stryker’s Neurovascular division said: “The unprecedented low complication rate shows that endovascular treatment may play an important role in optimizing clinical outcomes for patients suffering from this highly complex disease.”