Cooper University Health Care, in collaboration with the University of Iowa Health Care, has been awarded research funding by the Patient-Centered Outcomes Research Institute (PCORI) to support a large clinical trial comparing two triage strategies for guiding thrombectomy, a life-saving intervention for patients with large vessel occlusion (LVO) strokes.
The study, called DIRECT, is led by Dr. Santiago Ortega-Gutiérrez, clinical professor of neurology, neurosurgery, and radiology at UI Health Care, and Dr. Tudor Jovin, medical director of Cooper and Inspira Neuroscience and professor of neurology and neurological surgery at Cooper Medical School of Rowan University.
It seeks to determine whether a direct-to-angiosuite approach—bypassing the emergency department (ED) to expedite thrombectomy—can improve patient outcomes. The study will also assess whether this approach increases patient risk compared with conventional ED triage.
Faster stroke care saves lives
Stroke is a leading cause of long-term disability, affecting more than 795,000 people annually in the United States. LVO strokes, caused by blockages in major brain arteries, often lead to profound and permanent impairments.
Thrombectomy, a relatively new stroke treatment, involves using a catheter inserted through the groin or wrist to access the blocked artery and remove the clot, restoring blood flow. This procedure’s success depends on speed, as every minute of delay leads to the loss of thousands of brain cells.
Currently, stroke patients are typically triaged in the ED, where multiple imaging steps may delay treatment. Some hospitals have implemented a direct-to-angiosuite approach, where patients with suspected LVO are taken directly to the operating room or neurointerventional suite for immediate evaluation using flat-panel CT imaging.
“Time is brain, and in LVO patients, imaging often takes too long—so, in many ways, imaging is brain, too,” said Dr. Ortega-Gutiérrez, co-principal investigator of the DIRECT study. “Our recent research has shown that a direct-to-angiosuite strategy can accelerate treatment by at least 30 minutes—a time savings that can mean the difference between recovery and lifelong disability. This study is a landmark opportunity to rigorously evaluate this approach across diverse health care systems in the United States.”
“By confirming the benefits of this streamlined strategy, we aim to reshape stroke care paradigms and ensure that patients—regardless of where they are treated—have access to faster, more effective interventions,” he added.
Nationwide study to transform stroke triage
The DIRECT trial will enroll more than 2,000 patients across 20 leading thrombectomy centers in the U.S. to compare the direct-to-angiosuite approach with conventional ED triage.
“This trial is monumental in scale and significance,” said Dr. Jovin, co-principal investigator of the DIRECT study. “With more than 20 participating centers nationwide, we are poised to generate practice-changing evidence that addresses a critical gap in stroke care. Our findings will provide clinicians, hospitals, and policymakers with clear guidance on optimizing triage strategies to improve patient outcomes.”
“This study is not just about data—it’s about transforming care for patients facing one of the most severe and time-sensitive neurological emergencies,” added Dr. Jorge Cespedes, a postdoctoral researcher at UI Health Care and the DIRECT trial manager.
Patients enrolled in the study will contribute clinical data during hospitalization and complete follow-up assessments at three months, focusing on recovery, disability, and quality of life.
PCORI selected the study through its highly competitive review process, which includes input from patients, caregivers, and other stakeholders alongside scientists to evaluate research proposals.
About Cooper and Inspira Neuroscience
Cooper and Inspira Neuroscience is a partnership between Cooper University Health Care and Inspira Health dedicated to the diagnosis and treatment of neurological and neurosurgical conditions. The collaboration provides comprehensive surgical and nonsurgical services related to the brain, spinal cord, and central nervous system.
Cooper University Health Care’s Stroke Program has received The Joint Commission’s Gold Seal of Approval® and the American Heart Association/American Stroke Association’s Heart-Check mark for Advanced Certification for Comprehensive Stroke Centers—symbols of the highest level of stroke care.
About University of Iowa Health Care
University of Iowa Health Care is Iowa’s only comprehensive academic health system, providing advanced patient care, educating future physicians, and conducting biomedical research. With nearly 20,000 faculty and staff, UI Health Care is committed to improving health care and changing lives.
