1. A Global Case Report Form for the Evaluation of Peripheral Interventional Devices
Jose Pablo Morales, MD FDA Division of Cardiovascular Devices Center for Devices and Radiological Health (CDRH) CRT February 20, 2017

2. Disclosure Statement
I, Jose Pablo Morales, do not have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation

3. Registry Assessment of Peripheral Interventional Devices (RAPID)
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

4. Challenges in Evaluating Treatment of Peripheral Arterial Disease (PAD)
Heterogeneity complicates our evaluation of PAD treatment
Multiple different sized arteries and disease severity
Multiple specialties with different training, experience, bias
Multiple devices available for treating similar lesions:
Angioplasty Balloons: plain, drug coated, cutting, cryoplasty
Atherectomy Devices: laser, orbital, excisional
Stents: bare metal, covered, drug-eluting
Total occlusion crossing devices
Variation in treatment implies lack of adequate information

5. Solutions for Evaluating Treatment of PAD
Core data elements needed for device evaluation
Multi-specialty, industry and regulator consensus
Incorporation into registries, EHRs as discrete data elements
Real-world data extraction from multiple sources
Registries, EHR systems, industry, payers
Include procedures performed by different specialties
Use of same core data for all PAD treatment evaluation
Clinical trials, IDE studies, post-approval surveillance
Allow total product life cycle device evaluation
Incorporate all treatment types in same registry system
Medical management of PAD
Interventional and surgical treatment

6. RAPID
mdepinet.org/rapid

7. Phase 1: Define core data elements needed for device evaluation
Endovascular Today 2016: 15 (August)
Phase 1: Define core data elements needed for device evaluation
Phase 2: Incorporate core elements into registries, EHRs, CRFs
Phase 3: Extract core data from multiple sources for PAD treatment evaluation

8. RAPID Partners 3 Major U.S. 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)
5 International Partners
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
Global Medical Device Nomenclature Agency (GMDNA)
Australian Vascular Audit
German Vascular Society
Northern German Association for Vascular Medicine

9. RAPID Partners 7 U.S. Agencies
FDA (CDRH pre- and post-market, and CDER)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Medicare and Medicaid Services (CMS)
Department of Defense (DOD) Healthcare Resources
Office of the National Coordinator (ONC)
National Heart, Lung and Blood Institute (NHLBI)
National Library of Medicine (NLM)
6 EHR / Registry / Clinical Research Companies
Healthjump
Boston Biomedical Assoc.
Novella Clinical, Quintiles
Epic
M2S
MedStreaming

10. RAPID Partners 12 Device Manufacturers Abbott Aortic Medical Inc.
Avinger
Boston Scientific
Cardiovascular Systems Inc
Cook Medical
CR Bard
Medtronic
Spectranetics Corp
Terumo
Volcano Corp/Phillips Health Technology
WL Gore

11. RAPID Leadership Co-Chairs: Pablo Morales Robert Thatcher
Food and Drug Administration (FDA)
Robert Thatcher
4C Medical Technologies
Jack Cronenwett
Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI)
Project Manager:
Rebecca Wilgus
Clinical Informatics, Duke Clinical Research Institute (DCRI)
MDEpiNet Key Advisors:
Mitchell Krucoff, DCRI
Danica Marinac-Dabic, FDA

12. RAPID Phase 1: Core Data Elements
Started June, 2015 – Completed, August 1, 2016
Received and anonymized data elements from:
6 Society-based registry data forms
3 Major US Registries: ACC NCDR, SIR NIRQR, SVS VQI
3 International Registries: Australia, Germany, Japan
7 Device manufacturer case report forms
Bard, Boston Scientific, CSI, Cook, Gore, Medtronic, Terumo
DCRI Informatics staff analyzed 3,904 data elements
Selected and organized 2,021 variables that were specific to peripheral arterial device evaluation

13. RAPID Phase 1: Core Data Elements
Work Groups comprised of all stakeholders:
Multiple conference calls, face-face meetings
Clinical
Selected 100 core data elements most central to PVI device evaluation from the initial 2000 possible elements
Informatics
Developed technical specifications and meta data for each data element to support interoperability
Device Identification
Developed methods to incorporate global unique device identifier (GUDID) data into the core data set

14. RAPID Phase 1 Deliverables
Core Data Elements
Main elements, FDA device problem codes, medications, device categories central to PVI device evaluation
Use Cases for Core Data Elements
Pre- and post-market and randomized clinical trials
Workflow Diagrams
Point of care, total product lifecycle and registry-based clinical trials
GUDID Project Summary
Key learnings about use of GUDID data useful to other projects
Entering data into 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
Download at: mdepinet.org/rapid

15. RAPID Data Elements – Example
Data Element Label
Data Element Definition
Value set
Definitions of the elements of the value set
Reference source
CONDITION - MODIFIED RUTHERFORD CLASSIFICATION
Modified Rutherford Category
Categorical description of the symptoms associated with the obstruction of the lumen of the peripheral arteries (NCI C78533).
Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain
Adapted from VQI PVI registry, Rutherford J Vasc Surg 1997;26:517-38, ACC/AHA PAD Data Standards Circulation 2012;125: , and PARC J Am Coll Cardiol 2015. 1
Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields) 2
Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks ( feet, or 1-2 football fields) 3
Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field) 4
Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion 5
Minor tissue loss: nonhealing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia 6
Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive revascularization efforts

16. Clinical Data Element Highlights
Updated Rutherford Classification to include definitions of claudication distance
Adopted WIfI system for wound, infection grading
Patient functional status classification
Lesion calcification grading system
Detailed anatomic, lesion, device classification
Download data elements:

17. RAPID Phase 2-3 Progress
VQI has incorporated all RAPID core elements into its new PVI registry, including device identifier lookup with link to Access GUDID in NLM
Medstreaming has incorporated RAPID core data elements into its Vascular EMR system
This readies VQI for participation in interoperable data extraction for total life cycle PVI device evaluation
Other registries, EMR systems in progress
Key demonstration project in the new FDA National Evaluation System for Health Technology (NEST)
-Shuren J, Califf RM, JAMA, 2016: 316:

18. Summary
The multidisciplinary RAPID project provides a core data set that will allow interoperable data extraction from multiple sources for more efficient and coordinated national and international vascular device evaluation.
The RAPID data elements had been incorporated into VQI and Medstreaming, and ACC NCDR peripheral module working on it.
“This is an important step toward establishing the National Evaluation System for Health Technology” CDRH Director Jeff Shuren, MD, JD

19. Thank You