Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network.

Abstract

© Author(s) (or their employer(s)) 2022. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. INTRODUCTION Stroke is the leading cause of disability with treatment costs exceeding $46 billion between 2014 and 2015 in the USA alone. 2 Every year, approximately 795 000 Americans suffer a new or recurrent stroke resulting in nearly 140 000 deaths, with 87% being ischemic strokes. Deviceassisted interventions, such as endovascular mechanical thrombectomy, can be used for the emergent treatment of acute ischemic stroke. The comprehensive assessment of safety and effectiveness of deviceassisted treatments is complicated by several factors, including complex and unique neurovascular anatomy, the timing of stroke presentations, and variable tissue tolerability to ischemia. Realworld data (RWD) collected during routine medical care of patients presenting with acute ischemic stroke may be used to develop realworld evidence (RWE) to help evaluate the safety and effectiveness of deviceassisted treatments. The generated RWE may support postmarket surveillance requirements, identify potential adverse events, and perhaps guide regulatory decisions. For these reasons, the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) recognizes the potential value of RWE and its use in the course of clinical and regulatory decisionmaking when appropriate. Coordinated Registry Networks (CRNs) allow for the systematic aggregation of highquality RWD which can in turn be analyzed, potentially leading to relevant and reliable evidence for the evaluation of medical devices. 5 Prompted by participation in two public meetings in late 2015, FDA Public Meeting on Acute Ischemic Stroke and the Stroke Treatment Academic Industry Roundtable, the FDA began to consider initiating a registry to advance acute ischemic stroke clinical trials and, where appropriate, to capture data necessary to support regulatory, reimbursement, coverage, and physician decisionmaking. On February 2, 2017, the FDA held a Public Workshop on a CRN for Devices used for Acute Ischemic Stroke Interventions (DAISICRN). The purpose for this workshop was to obtain initial public stakeholders’ input and plan for future collaboration. On November 9, 2017, a multistakeholder group convened to launch the DAISI initiative. The mission of the DAISI initiative is to establish a CRN using RWE generated in the clinical care domain by patients, physicians, providers, and payers, for the purposes of enhancing regulatory and clinical decisionmaking, improving healthcare, and supporting the development of innovative devices to treat acute ischemic stroke. This CRN will use national and international databases to capture information from patient encounters with medical devices used to treat acute ischemic stroke using common data elements (CDEs) related to patient characteristics, medical history, the procedure, preoperative and postoperative imaging, treatment devices, technical outcomes, and clinical followup needed in the CRN for the assessment of successful revascularization using endovascular mechanical thrombectomy devices.