Trial design and oversight
acute stroke
ACUTE STROKE
The DEVT was a multicenter clinical trial with randomized treatment allocation, open-label treatment, and a blinded endpoint evaluation. The interventions were either EVT alone or intravenous alteplase plus EVT in patients with proximal anterior circulation occlusions treated within 4.5 hours of onset. All patients were admitted to acute stroke units, or intensive care units if needed, and treated following national and international guidelines. Detailed information about the main trial, including the treatments, blinding, statistical analysis, and determination of sample size, were described in the protocol and statistical analysis plan (SAP) of the DEVT [Trial investigators at the coordinating center collected the data for this extended follow-up trial. Members of the DEVT executive committee designed the extended follow-up trial, analyzed the data, prepared the manuscript, and made the decision to submit the manuscript for publication. The authors vouch for the accuracy and completeness of the available data from the extended follow-up trial and for the fidelity of the trial to the protocol. The study protocol was approved by medical ethics committee of the Second Affiliated Hospital of the Army Medical University and all participating centers. Written informed consent was obtained from the patient or patient’s representative, as required by national and local guidelines.