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

Methinks AI powers Done Symple trial to expand stroke treatment window to 24-72 hours using only non-contrast CT for patient selection.

BARCELONA, SPAIN, April 22, 2025 /EINPresswire.com/ -- 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.

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 nonprofit dedicated to improving stroke care through awareness, prevention, and research. It collaborates with healthcare professionals to expand access to treatment and support stroke survivors and their families. The foundation promotes equitable healthcare and funds research to reduce the global impact of stroke.

About Medtronic
Medtronic is a global leader in medical technology focused on advancing stroke care. The company develops innovative devices, including thrombectomy systems, to improve outcomes and expand access to life-saving treatment worldwide.

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.

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