Philips has announced a major clinical trial to assess the impact of a “direct to angio suite” workflow on stroke patient outcomes. The study will assess the role of Philips’ advanced image-guided therapy platform to diagnose, plan and treat stroke patients in the interventional suite without requiring an initial computed tomography (CT) or MRI exam. The multicentre, prospective, randomised, controlled, open-label, blinded-endpoint trial will be run across eight sites and over 460 patients globally. It will begin in the first half of next year and is expected to be completed in 2022.
According to a press release, several studies have already indicated that a direct to angio suite workflow can reduce the time to treatment and improve patient outcomes. The press release reports that Philips is developing new technology to further improve the CT-like images of the brain created with the X-ray system in the suite. The WE-TRUST (Workflow optimisation to reduce time to endovascular reperfusion in stroke treatment) trial aims to provide the most comprehensive assessment to-date of the impact of this technology and workflow innovation on time to treatment and patients’ neurological outcomes.
The trial will primarily be carried out on Philips Azurion at eight leading stroke sites in Europe and the USA. The primary endpoint of the trial is patients’ cognitive function at three months after the procedure.
Raul G Nogueira (Neuroendovascular Service Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Atlanta, USA), US principal investigator for the WE-TRUST trial, comments: “Significant advances in technology mean that we are now able to identify, plan and treat ischaemic stroke patients in the angiography suite, without the need for a separate CT or MR scan. Now is the right moment to perform a randomised controlled trial to objectively assess the benefits of a streamlined direct to angio suite workflow on patient outcomes.”
Ronald Tabaksblat, general manager, Image Guided Therapy Systems at Philips, says: “With extensive clinical research demonstrating the benefit of a treatment approach that combines thrombectomy and clot-busting drugs, stroke patient triage and treatment has changed dramatically in recent years. For stroke patients, ‘time is brain’. The WE-TRUST trial will assess the impact of a streamlined direct to angio suite workflow on patient outcomes and has the potential to make a significant impact in this rapidly advancing field.”