During the opening session of the SNIS Annual Meeting, J Mocco, MD, MS, Assistant Professor of Neurosurgery at The University of Florida in Gainesville, FL, announced the IDE approval and initiation of THERAPY, an industry-sponsored randomized controlled trial designed to prove the clinical benefit of interventional treatment of acute ischemic stroke. This first-ever landmark initiative could significantly impact the delivery of stroke treatment services in hospitals across the nation.
"Currently, catheter-based intervention in acute stroke patients has only been indicated for the removal of the clot causing stroke," Dr. Mocco, principal investigator of the trial, explained. "THERAPY, however, will assess the benefits of catheter-based intervention as a treatment standard for patients suffering stroke."
Stroke treatment has evolved significantly over the past two decades. Scientific advancement and innovation has led to the development of catheter-based intra-arterial therapeutic approaches to stroke which have extended the treatment time window from three hours to eight hours, improved the ability to emergently open blocked arteries and resulted in positive outcomes for thousands of patients. Despite the great promise of catheter-based treatments for stroke, however, rigorous randomized prospective trials are necessary to prove their efficacy and long-term viability. With the initiation of THERAPY, the opportunity now exists for the medical community to better assess whether interventional acute stroke treatment improves patients' future clinical outcomes. The results of such a study, study authors say, could potentially reframe the role of catheter-based stroke therapy in the near-term future.
"This is a very exciting time in the evolution of the neurointerventional field," said Cameron McDougall, MD, Chief of Endovascular Neurosurgery at Barrow Neurological Institute and President of the SNIS. "We are witnessing several ongoing or recently-initiated studies designed to assess many facets of intra-arterial therapy. THERAPY is a trial that has the potential to not only provide continued validation for intra-arterial techniques in the treatment of ischemic stroke, but also could prove that these techniques should be established as a cornerstone and standard in the armamentarium of treatment options for stroke in the future."
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