DAISI

Devices Used for Acute Ishchemic Stroke Intervention (DAISI)

The Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI) is an initiative that will be launched through a meeting at the FDA White Oak Campus on Thursday, November 9, 2017. The agenda for this meeting can be found at the following link (hyperlink to pages 1-2 and page 8 of the attached document).

Mission

The DAISI mission is to establish a nationwide and international Coordinated Registry Network (CRN) using Real World Evidence (RWE) generated in the course of clinical care by patients, physicians, providers, and payers, for the purposes of improving care and enhancing regulatory and other clinical decision-making. This CRN will include national and international database(s) that will be used to capture information from actual patient encounters with medical devices used to treat acute ischemic stroke. The RWE will support the advancement of acute ischemic stroke clinical trials and when and where appropriate, capture data necessary to support regulatory, reimbursement/coverage, and physician and patient decision-making.

Background

There are new device-based interventions to treat acute ischemic stroke that have been researched and developed by Sponsors, Investigators, and the clinical community, and approved by FDA. As technology continues to proliferate rapidly, the legacy approaches to evidence generation (randomized clinical trials ([RCT]) are becoming increasingly burdensome and have a potential to become obsolete by the time of completion. In addition, RWE needs to be taken into account for technologies that are well established or have become the standard of clinical care. Many decisions about use of these devices might be better made by using RWE instead of expensive, and often difficult to implement one-off studies.

The FDA is committed to supporting the sustainable generation and use of robust RWE throughout the medical device lifecycle, using Real World Data (RWD) generated in the course of clinical care by patients, providers, and payers, for the purpose of enhancing regulatory and other decision-making. Several of FDA’s ongoing strategic efforts align with FDA’s broader engagement under the National Evaluation Systems for health Technologies (NEST). This CRN, focused on acute ischemic stroke, will allow the capture of data from actual patient encounters with medical devices. The RWD will support the development of RWE that describes the outcomes of acute ischemic stroke treatments under different treatment conditions and when and where appropriate, captures data necessary to support regulatory, reimbursement/coverage, and physician and patient decision-making.