SAFE STEMI for Seniors: An International CRN-Based Prospective Randomized IDE Study of Labelling for Diagnostic and Therapeutic Devices Used in Seniors Suffering Heart Attack

Overview: This is a prospective randomized investigational device exemption (IDE) study for regulatory labelling of two devices, instantaneous flow reserve (IFR) diagnostic wires and therapeutic drug eluting stents in seniors undergoing urgent radial percutaneous coronary intervention (PCI) for ST-Elevation Myocardial Infarction (STEMI). Electronic data capture leverages international compatibility with the cardiac catheterization/percutaneous coronary intervention (NCDR CathPCI) registry and Medicare Claims data, including potential to auto-populate case report forms from registry and Claims sources.

Impact for NESTcc: Prospective randomized study using Real-World Data (RWD) for acute and follow-up “coordinated registry network” or CRN efficiencies in an IDE study.

Organization(s): Duke University/Duke Clinical Research Institute (DCRI); Center for Devices and Radiological Health (CDRH); Harvard University Quantitative Angiographic Core Laboratory; MDEpiNet Predictable and Sustainable Implementation of the National registries (PASSION) Cardiovascular Programs; Medtronic; National Cardiovascular Data Registry (NCDR); Terumo; The Center for Medicare and Medicaid Services (CMS); Volcano/Philips

Principal Investigator(s): David F. Kong, MD (DCRI); Roseann White, MA (DCRI); Mitchell W. Krucoff, MD (DCRI)