Peripheral Arterial Disease

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1 Peripheral Arterial Disease Registry Assessment of Peripheral Interventional Devices (RAPID) Launched June 5, 2015 Goal Standardize core data elements that could serve as a global case report form for both pre- and post-market assessment of peripheral arterial interventional devices

2 Co-Chairs Jack Cronenwett Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Pablo Morales Food and Drug Administration (FDA) Robert Thatcher Cardiovascular Systems, Inc. (CSI) Project Manager Rebecca Wilgus Clinical Informatics, Duke Clinical Research Institute (DCRI)

3 RAPID Partners Societies / Registries American College of Cardiology (ACC) National Cardiovascular Disease Registry (NCDR) Society of Interventional Radiology (SIR) National Interventional Radiology Quality Registry (NIRQR) Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Agencies FDA (pre- and post-market) Japan s Pharmaceuticals and Medical Devices Agency (PMDA) Centers for Medicare and Medicaid Services (CMS) MDEpiNet Coordinating Center Duke Clinical Research Institute (DCRI)

4 RAPID Partners Device Manufacturers Abbott Avinger Boston Scientific Cardiovascular Systems, Inc. Cook Medical Cordis CR Bard Medtronic Spectranetics Corp. Terumo Volcano Corp./Phillips Health Technology WL Gore

5 Lack of Consensus about PAD Rx Variable Patient Conditions Age, gender, diabetes influence outcomes Variable Disease Severity Claudication (life style) vs. Critical Ischemia (limb threat) Differing lesion length, occlusion vs. narrowing, calcification Variable Disease Location Large (iliac), Medium (SFA, popliteal), Small (tibial) Arteries Variable Physician Specialty, Training, Experience Cardiologists, radiologists, surgeons Variable Treatment Options Numerous device types, on- and off-label use in practice

6 Many Angioplasty Balloons Plain, drug coated, cutting, cryoplasty Stents Bare metal Self-expanding, balloon expandable Covered Drug-eluting Atherectomy devices Laser, mechanical Total occlusion crossing devices Many not approved for peripheral arterial treatment Non-standardized approach to device identification

7 RAPID Project Plan Phase I: Identify core minimum data set for registry assessment of lower extremity arterial devices Derive data elements from existing registries and industry case report forms used for pivotal device approvals Compare and contrast data elements assembled by DCRI informatics group Define core data elements and definitions, including patient and pathology data, device characteristics, endpoints for safety and effectiveness, and patient reported outcomes Clinical and Informatics Panels representing all RAPID partners Plan: HL7 balloting, linkage with ONC standards, sharing with EHR manufacturers to allow extraction from multiple sources

8 RAPID Project Plan Phase 1a: Develop a standardized approach to device identifier data elements supporting future integration of UDI. Work with FDA and National Library of Medicine to develop an automated method to periodically extract specific device data from Access GUDID to populate relevant registries Work with FDA and NLM to assess usefulness of current PVI device categorization and suggest improvements To be discussed in detail in Friday afternoon session

9 RAPID Project Plan Phase II: Develop data extraction interoperability across peripheral registries and hospital EHRs that provide patient-level data for core data elements. Pilot Projects: Incorporate data elements into registries (ACC, SIR, SVS) and EHR systems that are used by multiple hospitals Develop a solution to extract data elements from registries and EHRs from multiple hospitals to compile a single patient level database Provide core data elements to other national registries participating in the International Consortium of Vascular Registries (ICVR)

10 RAPID Project Plan Phase III: Apply a coordinated registries network (CRN) to prospective device evaluation to support a regulatory decision. Projects would extract minimal core data from different registries and hospitals to broadly access real world data Prospective clinical trial, pre-market device evaluation Post-market study, surveillance, IFU labelling expansion Objective performance criteria creation Goal: Total Product Life Cycle evaluation in real world practice

11 RAPID Progress Infrastructure Established DCRI Informatics Team, Project Manager Clinical and Informatics Expert Groups selected Multiple stakeholders represented in each group Registry and CRF forms, definitions submitted ACC NCDR, SIR, SVS VQI registries Nine manufacturers in process of submitting Full day planning meeting was held at FDA on June 5 Bi-weekly teleconferences of leadership group Break-out session today Full day working meeting at Heart House on Nov 6

12 Clinical Perspective Many devices in peripheral arteries used off-label Need to test effectiveness in real world setting after approval to allow best decision making and application Entering data into both CRFs and registries is expensive Using same data for multiple purposes is more cost-effective and allows more sites to participate in device evaluation Difficulty maintaining accurate list of devices in registries GUDID RAPID project provides mechanism to automate this Conflict across different specialties performing treatment RAPID provides mechanism for collaboration, learning Devices usually available in other countries before U.S. RAPID has potential for more efficient, early US device trials

13 Industry Perspective Realities Today Clinical trials for approval and indication expansion are expensive and time consuming Small approval studies required in various international geographies are not scientifically sound, compared to larger trials which have often already been completed. Clinical trials are narrow in patient populations studied due to many inclusion / exclusion criteria. They are not the Real World patients captured in registries today. Clinical trials, for similar patients, often have differing end points, data elements and definitions. Registries can capture safety signals and patient benefits missed in larger clinical trials Registries can also be expensive to develop and maintain

14 Industry Perspective The RAPID Future Vision Regulatory bodies around the globe agree to use pivotal trial, as well as, registry data to make approval, indication modification, and claims / label decisions Small (but expensive) geography specific trials are virtually eliminated over time Integrating EHR into registries amasses specific data acutely and longitudinally, allowing both clinical and economic analysis Patients and doctors benefit from lessons learned from the registries Industry benefits from rapid product improvement based on real world feedback in a timely fashion

15 FDA Perspective FDA has actively worked with manufacturers and professional societies on peripheral vascular projects Registries are useful data collection tools Pre-specified definitions and questions to be answered Common elements provide uniform data for FDA groups to analyze for similar devices Early engagement with industry, government agencies, and professional societies

16 FDA Perspective Potential to facilitate the assessment of devices and interventions through the global case report form Leads to ability to analyze large amount of data which allows for device-specific and device-type analysis (safety and effectiveness) Broader range of data can be used to support regulatory decisions and actions Pre-market approvals and post-market surveillance Total Product Life Cycle (TPLC)