1. RAPID and VISION September 10, 2018 VISION Think Tank Meeting
Daniel J. Bertges, MD
University of Vermont Medical Center
VQI PVI Registry Chair

2. Remember two things
1. Provide background and update on RAPID - Registry Assessment of Peripheral Intervention Devices and SFA-Popliteal EvidencE Development 2. RAPID partnership with VISION

3. RAPIDs Objective
To develop a public-private partnership to advance the nations approach to the evaluation of medical devices used to treat and manage peripheral artery disease throughout the total product life cycle

4. RAPID Leadership Principal Investigators MDEpiNet Key Advisors
Pablo Morales, MD, FDA
Robert Thatcher, 4C Medical Technologies
Jack Cronenwett, MD, Society for Vascular Surgery (SVS), Vascular Quality Initiative (VQI)
MDEpiNet Key Advisors
Mitchell Krucoff, MD, Duke Clinical Research Institute (DCRI)
Danica Marinac-Dabic, MD, PhD, MMSc, FDA
Project Management and Informatics Support
DCRI (Mina Baqai, Katy Knowlin, Sarah Palmer, Rebecca Wilgus)
Daniel Bertges, MD; Chair of VQI PVI registry 2014-present

5. RAPID- Registry Assessment of Peripheral Interventional Devices
Members include:
United States federal agencies (FDA, CMS, AHRQ, ONC, NHLBI, NLM)
Professional societies and their registries (VQI, NCDR, SIR)
Academia
Medical device manufacturers
International partners (ICVR)
Health information technology vendors
Clinical research organizations (DCRI, Weill Cornell Medical College)
Reference: Morales JP, Cronenwett J and Thatcher R. Endovascular Today 2016;15:85-94; Jones WS et al. J Vasc Surg 2018;67:637-45

6. RAPID- Registry Assessment of Peripheral Interventional Devices
Work Groups
Clinical Protocol & Statistics
Informatics
GUDID = Global Unique Device Identification Database
Governance
Outreach/Visibility

8. RAPID Phase 1 Completed! August, 2016 Endovascular Today August, 2016
mdepinet.org/rapid

9. PAD specific core data elements
Model for International Consortium of Vascular Registries

10. Use Cases

11. RAPID Progress Move beyond proof of concept
Combined project phase II/III that will use RAPID core data elements to facilitate peripheral device evaluation while addressing regulatory needs
SFA-Popliteal EvidencE Development

12. The Goal Of SPEED is to use the VQI PVI Database to develop contemporary, dynamic Objective Performance Goals (OPG) for Superficial Femoral & Popliteal Artery Endovascular Interventions
5/2/2018

13. Why SPEED? Actionable with available VQI data
Off the shelf ready: VQI incorporated RAPID core elements as of 9/2016
Multiple potential end users for OPGs
FDA, industry, physicians
Build out the infrastructure for future coordinated registry based device trials

14. Why SPEED OPGs?
Mature space but with new technologies (drug coated balloons and stents)
Many devices used off-label for patients with disease severity not tested in clinical trials
Difficult for physicians and impossible for patients to chose wisely
Current Objective Performance Goals for SFA-pop devices are out dated and do not reflect the current practice of medicine

17. Previous OPGs Small population 1,200 patients combined
Different endpoints (66% vs 39% 1-year restenosis, TVR)
Different disease severity (Rutherford 2-4 vs 4-6)
VIVA based on superiority vs PTA
SVS based on non-inferiority vs leg bypass
Data > 10 years old

18. “We hope that as the body of available clinical evidence becomes larger, the performance goals can be updated and further refined to reflect more robust data from endovascular approaches, from which performance goals can be generated for use in evaluating the next generation of devices.”
- Kumar, Brooks, Cavanaugh,Zuckerman JVS 2009

19. Outcomes of Interest Mortality, any cause
Major amputation: below or above knee amputation rate of index limb
Amputation free survival (AFS):): composite of freedom from mortality and major amputation
Target lesion revascularization (TLR): repeat intervention (open surgical or percutaneous) on the index artery(ies)
Open surgery: any endarterectomy or infrainguinal bypass of target lesion previously treated with PVI
Interventional: any angioplasty, atherectomy, stent or stent graft or thrombolysis performed on target lesion previously treated with PVI
Target lesion occlusion: binary loss of patency or occluded at follow-up
Target vessel revascularization: any reintervention within the target vessel
Technical failure: inability to cross lesion (with wire or device) or occlusion, or superficial femoral-popliteal artery dissection or perforation requiring treatment, or distal embolization requiring treatment, or residual stenosis >=30%. Excludes access site complications. Excludes device malfunction that is not specifically captured in VQI

20. Sample OPG Tables

21. RAPID and VISION Challenges of complex analysis
time and manpower costs are real
Solve or at least minimize the follow-up problem at least for core limb based outcomes
Fill blind spots in registries