“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.
Manesh R. Patel, MD∗; Michael S. Conte, MD†; Donald E. Cutlip, MD‡; Nabil Dib, MD‖; Patrick Geraghty, MD¶; William Gray, MD#; William R. Hiatt, MD††; Mami Ho, MD, PhD‡‡; Koji Ikeda, PhD§§; Fumiaki Ikeno, MD‖‖; Michael R. Jaff, DO¶¶; W. Schuyler Jones, MD∗; Masayuki Kawahara, MD‡‡; Robert A. Lookstein, MD##; Roxana Mehran, MD#; Sanjay Misra, MD∗∗∗; Lars Norgren, MD†††; Jeffrey W. Olin, MD##; Thomas J. Povsic, MD, PhD∗; Kenneth Rosenfield, MD‡‡‡; John Rundback, MD§§§; Fadi Shamoun, MD‖‖‖; James Tcheng, MD∗; Thomas T. Tsai, MD¶¶¶; Yuka Suzuki, PhD###; Pascal Vranckx, MD∗∗∗∗; Bret N. Wiechmann, MD††††; Christopher J. White, MD‡‡‡‡; Hiroyoshi Yokoi, MD§§§§; Mitchell W. Krucoff, MD∗