University Hospitals of Cleveland Receives Funding for SELECT LATE Study of Thrombectomy in Stroke

December 6, 2024—University Hospitals (UH) in Cleveland, Ohio, recently announced it was awarded $7 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to conduct a study titled, “Endovascular Thrombectomy in Patients Presenting beyond 24 Hours of Last-Known-Well (SELECT LATE).” The study abstract is available on the PCORI website here.

According to UH, SELECT LATE aims to provide deterministic evidence of clinical benefit caused by the addition of endovascular thrombectomy (EVT) to standard medical care in this population.

The study will be led by Principal Investigator Amrou Sarraj, MD, who is Director of Stroke Center and Stroke Systems at the UH Neurological Institute, the George M. Humphrey II Chair in Neurology at UH, and Professor of Neurology at Case Western Reserve University School of Medicine in Cleveland. Previously, Dr. Sarraj led the SELECT2 trial that established efficacy and safety of thrombectomy procedure in patients presenting with large strokes. The SELECT2 findings were published by Dr. Sarraj et al in The New England Journal of Medicine (2023;388:1259-1271).

As summarized in the UH press release, SELECT LATE will be conducted across sites in the United States, Canada, Europe, Australia, and New Zealand. Investigators will evaluate the benefits and risks of EVT for patients who present to the hospital beyond this usual time frame for treatment by randomly assigning them to receive either EVT or standard medical care. The study will compare how well patients in each group respond in terms of functional independence and quality of life as identified by the patients.

Additionally, the trial aims to reduce treatment disparities in elderly patients who live alone and those living in rural and remote communities. These patients often do not have timely access to health care, resulting in delayed presentation and potential disqualification from receiving this treatment, noted UH.

“Thrombectomy procedure has revolutionized how we treat patients with acute ischemic stroke due to occlusion in one of the larger brain vessels,” commented Dr. Sarraj in the UH press release. “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.”

Dr. Sarraj continued, “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 fold. 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.”

PCORI Executive Director Nakela L. Cook, MD, stated in the press release, “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 EVT 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.”

The $7 million funding is part of $156 million commitment to new studies announced by PCORI on December 3, 2024.

PCORI, based in Washington, DC, is an independent, nonprofit organization authorized by the United States Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, caregivers, and clinicians with the evidence-based information needed to make better-informed health and health care decisions, noted the press release.