Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC).
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.
Duke Clinical Research Institute, Duke University, Durham, North Carolina. Electronic address: manesh.patel@duke.edu.
Manesh R
MR
Patel
University of California-San Francisco, San Francisco, California.
Michael S
MS
Conte
Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Donald E
DE
Cutlip
University of California-San Diego, San Diego, California.
Nabil
N
Dib
Washington University Medical School, St. Louis, Missouri.
Patrick
P
Geraghty
Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center, New York, New York.
William
W
Gray
University of Colorado School of Medicine, and CPC Clinical Research, Aurora, Colorado.
William R
WR
Hiatt
Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Mami
M
Ho
Tohoku University Hospital, Sendai City, Miyagi, Japan.
Koji
K
Ikeda
Stanford University, Palo Alto, California.
Fumiaki
F
Ikeno
VasCore, Massachusetts General Hospital, Boston, Massachusetts.
Michael R
MR
Jaff
Duke Clinical Research Institute, Duke University, Durham, North Carolina.
W Schuyler
WS
Jones
Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Masayuki
M
Kawahara
Mount Sinai Medical Center, New York, New York.
Robert A
RA
Lookstein
Cardiovascular Research Foundation, New York, New York; Mount Sinai Medical Center, New York, New York.
Roxana
R
Mehran
Mayo Clinic, Rochester, Minnesota.
Sanjay
S
Misra
University Hospital, Orebro, Sweden.
Lars
L
Norgren
Mount Sinai Medical Center, New York, New York.
Jeffrey W
JW
Olin
Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Thomas J
TJ
Povsic
Massachusetts General Hospital, Boston, Massachusetts.
Kenneth
K
Rosenfield
Holy Name Medical Center, Teaneck, New Jersey.
John
J
Rundback
Mayo Clinic Arizona, Phoenix, Arizona.
Fadi
F
Shamoun
Duke Clinical Research Institute, Duke University, Durham, North Carolina.
James
J
Tcheng
Kaiser Permanente Colorado Institute for Health Research, University of Colorado, Denver, Colorado.
Thomas T
TT
Tsai
Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yuka
Y
Suzuki
Cardialysis, Rotterdam, the Netherlands.
Pascal
P
Vranckx
Vascular and Interventional Physicians, Gainesville, Florida.
Bret N
BN
Wiechmann
Ochsner Medical Center, New Orleans, Louisiana.
Christopher J
CJ
White
Kokura Memorial Hospital, Kitakyuku, Japan.
Hiroyoshi
H
Yokoi
Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Mitchell W
MW
Krucoff
D017130:Angioplasty; D017073:Atherectomy; D001807:Blood Vessel Prosthesis; D003251:Constriction, Pathologic / Q000628:therapy; D003952:Diagnostic Imaging; D004691:Endarterectomy; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D063868:Patient Outcome Assessment; D058729:Peripheral Arterial Disease / Q000145:classification / Q000175:diagnosis* / Q000628:therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D015607:Stents; D016138:Walking
amputation; foot; intermittent claudication; leg; myocardial infarction; stroke