University Hospitals (UH) has been awarded $7 million by the Patient-Centered Outcomes Research Institute (PCORI) to conduct a study on endovascular thrombectomy (EVT) in stroke patients who present more than 24 hours after they were last known to be symptom-free. Amrou Sarraj, MD, Director of the Stroke Center and Stroke Systems at the UH Neurological Institute, will lead the SELECT Late trial, which seeks to provide definitive evidence of the clinical benefit of adding EVT to standard medical care for this patient population.
Addressing the Late Presentation Challenge in Stroke Treatment
EVT, a procedure involving the removal of a blood clot from the brain using a catheter, is a primary treatment for acute ischemic stroke. Its effectiveness has been established for patients treated within 24 hours of symptom onset. However, a significant number of stroke patients arrive at the hospital after this critical window, limiting their treatment options. Currently, only about 10% of patients presenting with a large vessel occlusion after 24 hours receive EVT, according to Get-with-the-Guidelines data.
The SELECT Late trial will be conducted across sites in the U.S., Canada, Europe, Australia, and New Zealand. Patients presenting beyond the 24-hour window will be randomly assigned to receive either EVT or standard medical care. Researchers will then compare the two groups in terms of functional independence—the ability to perform daily tasks without assistance—and patient-reported quality of life.
Expert Perspectives on the Trial's Significance
"Thrombectomy procedure has revolutionized how we treat patients with acute ischemic stroke due to occlusion in one of the larger brain vessels. However, the current evidence of efficacy and safety is limited to those presenting within 24 hours of when they were last known to be without symptoms," said Dr. Sarraj. "For patients who present beyond this timeframe, a lack of randomized evidence prevents us from treating them universally with this state-of-the-art technology that is shown to improve stroke outcomes by two to three folds. We expect this to help many patients; those who live alone without early recognition of their symptoms, especially the elderly, and patients who do not have prompt access to thrombectomy centers."
Reducing Treatment Disparities
The trial also aims to address treatment disparities affecting elderly patients living alone and those in rural or remote communities. These individuals often face delays in accessing healthcare, potentially disqualifying them from receiving EVT. By including these populations, the study seeks to ensure equitable access to advanced stroke care.
Nicholas Bambakidis, MD, Vice President and Director of the UH Neurological Institute, emphasized the importance of the trial: "University Hospitals and Case Western Reserve University have always been at the forefront of medical advances. The SELECT Late global trial will have a tremendous impact on acute stroke management, not only individually but also in terms of how we organize stroke systems of care."
Dr. Sarraj added, "We expect a major impact on systems of care and the current patients' transfer practice since these patients are vastly not being considered for transfer for higher level of care and consideration of thrombectomy."
PCORI's Commitment to Patient-Centered Research
Nakela L. Cook, MD, MPH, PCORI Executive Director, stated, "This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders, but also for its conduct in real-world settings. It has the potential to answer an important question about the utility of endovascular thrombectomy in this vulnerable patient population and fill a crucial evidence gap. We look forward to following the study’s progress and working with University Hospitals Cleveland Medical Center to share its results."
