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J Am Coll Cardiol. 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).

Author information

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.

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

PMID:
25744011
PMCID:
PMC4874808
DOI:
10.1016/j.jacc.2014.12.036
[Indexed for MEDLINE]
Free PMC Article

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