Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional...

Area of Science:

• Cardiovascular Research
• Medical Device Epidemiology
• Health Informatics

Background:

• Evaluating peripheral vascular intervention (PVI) devices is complex due to disease heterogeneity, diverse specialties, numerous devices, and lack of treatment consensus.
• Current PVI data elements lack standardization across clinical care, trials, and registries, hindering data aggregation and analysis.
• This limits effective device evaluation and surveillance for all stakeholders.

Purpose of the Study:

• To address challenges in peripheral artery disease (PAD) and PVI device evaluation.
• To develop a consensus lexicon and promote interoperability for PVI data.
• To establish a framework for standardized reporting and pragmatic clinical trials in PVI.

Main Methods:

• Convened the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup under the FDA's Medical Device Epidemiology Network initiative.
• Focused on developing a collaborative, multidisciplinary effort to standardize clinical data elements and definitions.
• Aimed to implement an informatics-based approach for PVI clinical trials and registries.

Main Results:

• The RAPID workgroup has initiated efforts to standardize clinical data elements and definitions for PVI.
• A framework is being established for electronic health records and procedural reporting systems.
• An informatics-based approach is being implemented to support pragmatic clinical trials and registry efforts.

Conclusions:

• Standardized data elements and definitions are essential for PVI device evaluation.
• Improved data interoperability will facilitate better device surveillance and patient outcomes.
• This initiative aims to enhance evaluation and surveillance for patients, clinicians, researchers, industry, and regulators.