Methinks AI has announced that it has been chosen as the patient selection software for the DONE SYMPLE trial—a randomised controlled trial (RCT) aimed at simplifying imaging protocols and expanding access to treatment for very-late-window (24–72 hours) stroke patients.
The trial, led by interventional neurologists Santiago Ortega-Gutiérrez (University of Iowa Health Care, Iowa City, USA), Marc Ribó (Hospital Vall d’Hebrón, Barcelona, Spain), and Tudor Jovin (Cooper Neurological Institute, Cherry Hill, USA), is backed by Medtronic via an investigator-initiated grant and sponsored by Spanish non-profit organisation Fundació Ictus.
“We truly believe that Methinks can help identify patients who would benefit from thrombectomy in the extended window,” commented global principal investigator Ortega-Gutiérrez. “The accuracy of the selection tool is critical to the trial’s success, and Methinks has already demonstrated superior performance compared to the current gold-standard CT [computed tomography] perfusion for late-window patient selection.”
DONE SYMPLE is set to evaluate the efficacy of endovascular therapy (EVT) in late-window stroke patients using only non-contrast CT (NCCT) for imaging—eliminating the need for CT angiography (CTA) or perfusion (CTP). This approach is designed to streamline patient selection, reduce delays, and increase access to thrombectomy, particularly in Latin American (LATAM) countries, where the trial will be conducted, and other lower-resource regions in which CTA and CTP are not widely available.
Methinks AI states in a recent press release that its cutting-edge modules for large vessel occlusion (LVO) detection and ischaemia volume measurement will be a critical part of the trial, enabling precise, artificial intelligence (AI)-driven patient selection based on non-contrast imaging.
As “the first” CE-marked medical device capable of detecting both hyperdense and non-hyperdense LVOs from NCCT and CTA—as well as identifying intracerebral haemorrhages (ICHs) from NCCT scans—Methinks AI’s goal is to redefine stroke care by building the best AI for non-contrast imaging and providing a coordination solution seamlessly integrated in Microsoft Teams. By utilising widely available imaging technology, the company is attempting to facilitate early, rapid and accurate triaging of stroke patients across diverse healthcare settings, expanding access to life-saving interventions in underserved communities.
For the DONE SYMPLE trial, eligible patients must meet specific criteria, including stroke alerts, National Institutes of Health stroke scale (NIHSS) scores >7, suspected LVO on Methinks AI NCCT analysis, ischaemia volume <70ml, and a last-seen-well time between 24–72 hours. Participants will be randomised to receive either standard-of-care best medical treatment or EVT plus best medical treatment, with outcomes measured by the modified Rankin scale (mRS) at 90 days. The primary hypothesis is that EVT will lead to better outcomes in terms of 90-day mRS scores.
“We are proud to be part of this groundbreaking study and to collaborate with such outstanding investigators,” said Pau Rodríguez, chief executive officer (CEO) of Methinks AI. “A positive outcome in this study will further validate our technology’s potential to improve stroke care worldwide—particularly in underserved regions—saving lives and preventing disabilities.”
