April 3, 2018 – RAPID and SAFE STEMI for Seniors were among 11 projects selected to provide proof of concept for new approaches to real-world evidence generation.
The National Evaluation System for health Technology Coordinating Center (NESTcc) selected two DCRI projects as Medical Device Real-World Evidence Demonstration Projects: Registry Assessment of Peripheral Interventional Devices (RAPID) and Study of Access Site for Enhancing PCI in STEMI (SAFE STEMI for Seniors).
A total of 11 demonstration projects were recognized for their potential to provide proof of concept for innovative and scalable approaches to real-world evidence generation across the medical device total product life cycle (TPLC).
NESTcc was established by the Medical Device Innovation Consortium (MDIC) to serve as a catalyst in establishing functional and efficient pathways for key stakeholders to generate quality, low-cost, near-time real-world evidence for regulatory, coverage, patient, and clinical decision-making.
The RAPID program, comprised of three phases, is focused on devices for peripheral arterial intervention as an archetype of the envisioned TPLC. In addition, it leverages collaborative leadership and methodologies to advance interoperable collection and exchange of electronic health information related to the care and treatment of patients with peripheral arterial disease. Throughout the phases, RAPID aims to:
- Prioritize data elements
- Extract registry or EHR data to develop objective performance goals for specific devices and optimize device identification protocols
- Bring together interoperable datasets from multiple RAPID data partners to support a regulatory decision
SAFE STEMI for Seniors is an investigator-initiated, multicenter, randomized, open-label, unblinded, active, and historical controlled trial in which approximately 875 seniors undergoing urgent PCI from at least 70 centers in North America will be enrolled. All consented subjects will undergo attempted radial arterial access. SAFE STEMI for Seniors is currently enrolling patients and recruiting investigational sites.