. 2015 Mar 10;65(9):931-41.

doi: 10.1016/j.jacc.2014.12.036.

Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC)

Manesh R Patel¹, Michael S Conte², Donald E Cutlip³, Nabil Dib⁴, Patrick Geraghty⁵, William Gray⁶, William R Hiatt⁷, Mami Ho⁸, Koji Ikeda⁹, Fumiaki Ikeno¹⁰, Michael R Jaff¹¹, W Schuyler Jones¹², Masayuki Kawahara⁸, Robert A Lookstein¹³, Roxana Mehran¹⁴, Sanjay Misra¹⁵, Lars Norgren¹⁶, Jeffrey W Olin¹³, Thomas J Povsic¹², Kenneth Rosenfield¹⁷, John Rundback¹⁸, Fadi Shamoun¹⁹, James Tcheng¹², Thomas T Tsai²⁰, Yuka Suzuki²¹, Pascal Vranckx²², Bret N Wiechmann²³, Christopher J White²⁴, Hiroyoshi Yokoi²⁵, Mitchell W Krucoff¹²

Affiliations

¹ Duke Clinical Research Institute, Duke University, Durham, North Carolina. Electronic address: manesh.patel@duke.edu.
² University of California-San Francisco, San Francisco, California.
³ Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts.
⁴ University of California-San Diego, San Diego, California.
⁵ Washington University Medical School, St. Louis, Missouri.
⁶ Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center, New York, New York.
⁷ University of Colorado School of Medicine, and CPC Clinical Research, Aurora, Colorado.
⁸ Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
⁹ Tohoku University Hospital, Sendai City, Miyagi, Japan.
¹⁰ Stanford University, Palo Alto, California.
¹¹ VasCore, Massachusetts General Hospital, Boston, Massachusetts.
¹² Duke Clinical Research Institute, Duke University, Durham, North Carolina.
¹³ Mount Sinai Medical Center, New York, New York.
¹⁴ Cardiovascular Research Foundation, New York, New York; Mount Sinai Medical Center, New York, New York.
¹⁵ Mayo Clinic, Rochester, Minnesota.
¹⁶ University Hospital, Orebro, Sweden.
¹⁷ Massachusetts General Hospital, Boston, Massachusetts.
¹⁸ Holy Name Medical Center, Teaneck, New Jersey.
¹⁹ Mayo Clinic Arizona, Phoenix, Arizona.
²⁰ Kaiser Permanente Colorado Institute for Health Research, University of Colorado, Denver, Colorado.
²¹ Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
²² Cardialysis, Rotterdam, the Netherlands.
²³ Vascular and Interventional Physicians, Gainesville, Florida.
²⁴ Ochsner Medical Center, New Orleans, Louisiana.
²⁵ Kokura Memorial Hospital, Kitakyuku, Japan.

PMID: 25744011
PMCID: PMC4874808
DOI: 10.1016/j.jacc.2014.12.036

Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC)

Manesh R Patel et al. J Am Coll Cardiol. 2015.

. 2015 Mar 10;65(9):931-41.

doi: 10.1016/j.jacc.2014.12.036.

Authors

Affiliations

¹ Duke Clinical Research Institute, Duke University, Durham, North Carolina. Electronic address: manesh.patel@duke.edu.
² University of California-San Francisco, San Francisco, California.
³ Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts.
⁴ University of California-San Diego, San Diego, California.
⁵ Washington University Medical School, St. Louis, Missouri.
⁶ Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center, New York, New York.
⁷ University of Colorado School of Medicine, and CPC Clinical Research, Aurora, Colorado.
⁸ Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
⁹ Tohoku University Hospital, Sendai City, Miyagi, Japan.
¹⁰ Stanford University, Palo Alto, California.
¹¹ VasCore, Massachusetts General Hospital, Boston, Massachusetts.
¹² Duke Clinical Research Institute, Duke University, Durham, North Carolina.
¹³ Mount Sinai Medical Center, New York, New York.
¹⁴ Cardiovascular Research Foundation, New York, New York; Mount Sinai Medical Center, New York, New York.
¹⁵ Mayo Clinic, Rochester, Minnesota.
¹⁶ University Hospital, Orebro, Sweden.
¹⁷ Massachusetts General Hospital, Boston, Massachusetts.
¹⁸ Holy Name Medical Center, Teaneck, New Jersey.
¹⁹ Mayo Clinic Arizona, Phoenix, Arizona.
²⁰ Kaiser Permanente Colorado Institute for Health Research, University of Colorado, Denver, Colorado.
²¹ Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
²² Cardialysis, Rotterdam, the Netherlands.
²³ Vascular and Interventional Physicians, Gainesville, Florida.
²⁴ Ochsner Medical Center, New Orleans, Louisiana.
²⁵ Kokura Memorial Hospital, Kitakyuku, Japan.

PMID: 25744011
PMCID: PMC4874808
DOI: 10.1016/j.jacc.2014.12.036

Erratum in

J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9

Abstract

The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.

Keywords: amputation; foot; intermittent claudication; leg; myocardial infarction; stroke.

PubMed Disclaimer

Figures

**CENTRAL ILLUSTRATION. PARC-PAD Definitions: Consensus Definitions for Evaluation of Patients With Lower Extremity Peripheral Artery Disease: The PARC**
The Peripheral Academic Research Consortium (PARC) included input from both the Food and Drug Administration and the Pharmaceuticals and Medical Devices Agency to develop consensus definitions. Patient features and clinical care data will be entered into patients’ electronic health records (EHRs) used in peripheral artery disease (PAD) registries for clinical trials, and were on the basis of the data elements for PAD in the 2012 American Heart Association/American College of Cardiology (AHA/ACC) data standards document (9). Patient features and clinical care data, data elements, and PAD registries all are used in clinical trials.

See this image and copyright information in PMC

References

1. Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011;58:2020–45. - PMC - PubMed
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Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC)

Affiliations

Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC)

Authors

Affiliations

Erratum in

Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Molecular Biology Databases