Done Symple Trial Leverages Methinks AI Software to Expand Stroke Treatment Window 

Methinks AI, a leader in artificial intelligence-driven stroke assessment, has been selected as the patient selection software for the Done Symple trial – an ambitious randomized controlled trial (RCT) aimed at simplifying imaging protocols and expanding access to treatment for very late-window stroke patients (24-72 hours). 

The trial, led by renowned interventional neurologists Dr. Santiago Ortega-Gutiérrez (Cerebrovascular & Neurointerventional Lab, UIHC), Dr. Marc Ribó (Hospital Vall d’Hebrón, Barcelona), and Dr. Tudor Jovin (Cooper Neurological Institute, New Jersey), is backed by Medtronic (Irvine, CA) and sponsored by Fundació Ictus, a Barcelona-based nonprofit supporting stroke patients and their families. 

Revolutionizing Stroke Treatment Accessibility 

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 countries (LATAM), where the trial will be conducted, and other lower-resource regions, where CTA and CTP are not widely available.

Also Read: Medtronic Partners with Methinks AI to Enhance Stroke Care

Methinks AI’s cutting-edge modules for Large Vessel Occlusion (LVO) detection and ischemia volume measurement will be a critical part of the trial, enabling precise, 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 (ICH) from NCCT scans, Methinks AI is redefining stroke care by focusing on building the best AI for non-contrast imaging and providing a coordination solution seamlessly integrated in Microsoft Teams. By utilizing widely available imaging technology, Methinks AI facilitates early, rapid, and accurate triaging of stroke patients across diverse healthcare settings, expanding access to life-saving interventions in underserved communities.

Eligible patients must meet specific criteria, including stroke alerts, NIHSS > 7, suspected LVO on Methinks NCCT analysis, ischemia volume < 70ml, and a last-seen-well time between 24-72 hours. Participants will be randomized to receive either standard-of-care best medical treatment or EVT + 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, as measured by the modified Rankin Scale (mRS) at 90 days. 

“We are proud to be part of this groundbreaking study and to collaborate with such outstanding investigators,” said Pau Rodríguez, CEO of Methinks. “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.” 

Dr. Santiago Ortega-Gutiérrez, the global principal investigator for Done Symple, emphasized the role of Methinks AI in the trial: “We truly believe that Methinks can help identify patients who would benefit from thrombectomy in the extended window. 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 Perfusion for late-window patient selection.” 

Advancing Global Stroke Research and Innovation 

Fundació Ictus, the study sponsor, is supporting Done Symple through an investigator-initiated grant from Medtronic, a global leader in medical technology. The nonprofit remains dedicated to improving stroke care by providing comprehensive patient support, raising awareness, and driving research and innovation. 

With the support of such reputed institutions and investigators, the Done Symple trial has the potential to revolutionize stroke treatment, extending life-saving interventions to millions worldwide. 

About Fundació Ictus 

Fundació Ictus is a leading nonprofit organization committed to transforming stroke care through awareness, prevention, and research. Working closely with healthcare professionals and institutions, the foundation drives innovation in treatment, expands access to life-saving care, and provides crucial support for stroke survivors and their families. By advocating for equitable healthcare solutions and funding groundbreaking research, Fundació Ictus is dedicated to reducing the global impact of stroke and improving long-term patient outcomes. 

About Medtronic 

Medtronic is a global leader in medical technology, committed to advancing stroke care through innovative solutions that improve patient outcomes. The company develops cutting-edge devices for stroke treatment, including thrombectomy systems that enable faster and more effective interventions. By working closely with healthcare professionals and institutions worldwide, Medtronic aims to enhance access to life-saving treatments and reduce the global burden of stroke. 

About Methinks AI 

Methinks AI is a pioneering company in the development of Artificial Intelligence software for the early assessment of stroke. It is the first CE-marked medical device capable of detecting large vessel occlusions, both hyperdense and non-hyperdense, as well as intracerebral hemorrhages using non-contrast computed tomography. This technology helps optimize stroke patient triage and reduce time to treatment, significantly improving clinical outcomes.

MedTech Malta 2025

Mark your calendar for 12-14 November as MedTech Malta returns to Valletta—your gateway to meaningful connections and practical innovation in the Mediterranean. Whether you’re a startup ready to pitch, a company exploring sponsorships, or a professional eager to learn and connect, this is where you want to be. Expect sharp panels, curated networking, and the buzz of the MedTech Startup Pitch Competition. Want in? Reach out at [email protected] and grab your early bird ticket before prices go up.