TY - JOUR
T1 - Evaluation and treatment of patients with lower extremity peripheral artery disease
T2 - Consensus definitions from peripheral academic research consortium (PARC)
AU - Patel, Manesh R.
AU - Conte, Michael S.
AU - Cutlip, Donald E.
AU - Dib, Nabil
AU - Geraghty, Patrick
AU - Gray, William
AU - Hiatt, William R.
AU - Ho, Mami
AU - Ikeda, Koji
AU - Ikeno, Fumiaki
AU - Jaff, Michael R.
AU - Jones, W. Schuyler
AU - Kawahara, Masayuki
AU - Lookstein, Robert A.
AU - Mehran, Roxana
AU - Misra, Sanjay
AU - Norgren, Lars
AU - Olin, Jeffrey W.
AU - Povsic, Thomas J.
AU - Rosenfield, Kenneth
AU - Rundback, John
AU - Shamoun, Fadi
AU - Tcheng, James
AU - Tsai, Thomas T.
AU - Suzuki, Yuka
AU - Vranckx, Pascal
AU - Wiechmann, Bret N.
AU - White, Christopher J.
AU - Yokoi, Hiroyoshi
AU - Krucoff, Mitchell W.
N1 - Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/3/10
Y1 - 2015/3/10
N2 - 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.
AB - 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.
KW - amputation
KW - foot
KW - intermittent claudication
KW - leg
KW - myocardial infarction
KW - stroke
UR - http://www.scopus.com/inward/record.url?scp=84924690336&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2014.12.036
DO - 10.1016/j.jacc.2014.12.036
M3 - Review article
C2 - 25744011
AN - SCOPUS:84924690336
SN - 0735-1097
VL - 65
SP - 931
EP - 941
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 9
ER -