Testing the Use of Real-World Data from Three Unique Sources to Expand Indications

This project focused on designing, collecting, and examining Real-World Data (RWD) about the novel application of an endovascular stent graft for patients with complex abdominal aortic aneurysms. Stent grafts are a flexible metal wire structure covered with an impermeable material used to treat aneurysms or weakening in the walls of blood vessels. Stent grafts prevent aneurysms from rupturing and potentially causing death.

This project used three unique data sources and a specific case identification algorithm to study new ways surgeons have adapted an existing stent graft. The device of interest is made of two components: a main body implanted in the common iliac artery and an iliac stent that extends into the internal iliac artery. Data were collected from three Real-World Data sources: the Vascular Quality Initiative (a Coordinated Registry Network that is part of MDEpiNet), a statewide clinical research network (OneFlorida), and a regional quaternary health system (DukeHealth).

This Test-Case studied how specific endovascular graft cases using the two components can be identified from these data sources and evaluate clinical outcomes for cases using the device of interest. Information collected from these RWD sources can be used to guide decisions by physicians, payers, and regulatory agencies about potential FDA approval of the main body device in conjunction with the iliac stent, a new device as a component of a larger system.

Additionally, this project can help researchers learn about the utility of these new approaches both in the treatment of different aneurysms as well as how this type of data can be applied to regulatory submissions.