Vascular Cures hosts our biennial Innovation & Research Summits to prioritize pressing needs in vascular research and care, and to identify collaborative solutions.

The best ideas (and most-needed solutions) are turned into internal programs, special initiatives, and collaborative working groups.

CLTI Patient Engagement

(2021-2023)

Promoting and facilitating the inclusion of Chronic Limb-Threatening Ischemia (CLTI) patients in research.
Project Overview

Chronic limb-threatening ischemia (CLTI) is an advanced form of peripheral artery disease (PAD) that can lead to amputation. People living with CLTI have a wealth of lived experiences to share that are distinct from the researchers who design and conduct trials to improve outcomes. Unfortunately, there is a lack of patient participation in research study design and execution. This means researchers struggle to find diverse and representative trial participants, and that study results do not always answer questions that are important to CLTI patients.

To help address this problem, Vascular Cures is convening a Working Group to promote and facilitate CLTI patient engagement in research. This initiative will build capacity to engage CLTI patients in research as advisors and participants, so that study results align with the needs of patients. It will also prioritize the kinds of research that are most important to patients.

Ultimately, this work will create new knowledge and treatments that more closely align with CLTI patient needs and improve health outcomes.

 

Working Group participants are dedicated to building a future in which academic researchers, industry partners, and people with CLTI can effectively collaborate to design and implement patient-centered trials with a high likelihood of success. Members include representatives from patient care and research (vascular surgery, cardiology, podiatry, diabetology, vascular medicine), regulatory and policy, reimbursement, health systems, professional societies, patient advocacy, and patients themselves.

Working Group Members:
Organizers:
  • Michael Conte, MD – Vascular Cures/UCSF
  • Sherene Shalhub, MD – University of Washington
  • Manesh Patel, MD – Duke University
  • E. Hope Weissler, MD – Duke University
Patients:
  • Bill – Patient Advocate
  • Cheryl – Patient Advocate
  • Dominque – Patient Advocate/Caregiver
  • Jenny – Patient Advocate
  • Jim – Patient Advocate
  • Kim – Patient Advocate
  • Mechket – Patient Advocate
  • PW – Patient Advocate/Caregiver
  • Sara – Patient Advocate
Medical Research & Care:
  • Olamide Alabi, MD – Emory University
  • David G. Armstrong, PhD, DPM – University of Southern California
  • Matthew A. Corriere, MD, MS – University of Michigan
  • Patrick Geraghty, MD – Washington University
  • Phillip Goodney, MD, MS – Dartmouth College
  • Misty Humphries, MD, MAS – UC Davis
  • Matthew T. Menard, MD – Harvard University
  • Samantha Minc, MD, MPH – West Virginia University
  • Anne L. Peters, MD – University of Southern California
  • Vincent Rowe, MD – University of Southern California
  • Jessica Simons, MD, MPH – University of Massachusetts
  • Diane Treat-Jacobson, PhD, RN – University of Minnesota
FDA/NIH:
  • Allen Chen, PhD – FDA, CDRH
Industry:
  • Tammy Leitsinger – Silkroad Medical
  • Jim Wilson – Cardiovascular Systems, Inc.
Payer:
  • Kevin Heath, MD – OptumCare
Patient Advocacy:
  • Kymberlie McNicholas – Way To My Heart

Patient-Reported Outcome Measures in PAD

(2018-2021)

Advancing patient-centered outcome measures in Peripheral Artery Disease
Project Overview

Peripheral artery disease (PAD) affects hundreds of millions of people around the world, causing disability, functional decline, limb loss, and death. Yet we understand relatively little about how the disease or the treatments we offer affect patients in their everyday lives. It has become critical that we develop standardized approaches to capture direct patient-reported outcome measures (PROMs) in PAD so that we can better measure clinical effectiveness and value in vascular care, and design treatments that are truly impactful. Incorporation of these PROMs into clinical trials, registries, and everyday practice provides a way forward to patient-centered care for the vascular patient.

To help improve the use of PROMS in PAD, Vascular Cures created the PROM-PAD Working Group. The 2019 kickoff meeting of this group in the nation’s capital brought together a multi-disciplinary group of clinical experts, scientists, governmental and industry stakeholders — as well as several patients with PAD who provided direct and powerful input. We are proud to have catalyzed this important work.  

In 2022 the PROM-PAD working group published two papers that will advance this field. The goal of the effort was not simply to provide recommendations to the PAD community, but to catalyze implementation of PROMs in a feasible, meaningful, and scientifically sound fashion to improve the lives of patients with PAD. 

For a summary of the papers, click here.

Publications:
Working Group Members:
Organizers:
  • Michael Conte, MD – Vascular Cures/UCSF
  • Manesh Patel, MD – Duke University
  • Jennifer Rymer, MD, MBA – Duke University
Patients:
  • Gertrude – Patient Advocate
  • Steve – Patient Advocate
  • Pamela – Patient Advocate
  • Samuel – Patient Advocate
Medical Research & Care:
  • Victor Aboyans, MD, PhD – Dupuytren University Hospital, Limoges, France
  • David G. Armstrong, PhD, DPM – USC Keck School of Medicine
  • Matthew A. Corriere, MD, MS – University of Michigan
  • Patrick Geraghty, MD, FACS – Washington University
  • Phillip Goodney, MD, MS – Dartmouth College
  • Naomi M. Hamburg, MD, MS – Boston University
  • William Hiatt, MD – University of Colorado
  • Scott Kinlay, PhD, MBBS – Harvard University
  • Robert Lookstein, MD – Mount Sinai
  • Mary McDermott, MD – Northwestern University
  • Matthew T. Menard, MD – Harvard University
  • Kim G. Smolderen, PhD – Yale University
  • Bjoern Suckow, MD, MS – Dartmouth College
  • Samir Kaushik Shah, M.D. – University of Florida
  • Diane Treat-Jacobson, PhD, RN – University of Minnesota
FDA/NIH:
  • Donna Buckley, MD – FDA, CDRH
  • Joseph Chin, MD – CMS
  • Ebony Dashiell-Aje, PhD – FDA, CDER
  • Zorina Galis, PhD – NHLBI
  • Misti Malone, PhD – FDA, CDRH
  • Norman Stockbridge, MD, PhD – FDA, CDER
Industry:
  • Jason Belzer – Abbott Vascular
  • James Hasegawa – Abbott Vascular
  • Julie Prillinger, PhD – Abbott Vascular
  • Jason Exter – Amgen
  • Stefanie Kespohl, PhD – Bayer
  • Lars Schwichtenberg, PhD – Bayer
  • Christine Prinzivalli – Boston Scientific
  • Cole Scattarelli – Boston Scientific
  • Aaron Lottes, PhD – Cook Medical
  • Pete Polverini – Cook Medical
  • Merrill Birdno, PhD – Gore
  • Ann Ensley, PhD – Gore
  • Daniel Dadourian, MD – Janssen
  • Peter Wildgoose, PhD – Janssen
  • Arslan Malik, MBBS, MBA – Medtronic
  • Anna Szafranski – Medtronic