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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Patel, MR; Conte, MS; Cutlip, DE; Dib, N; Geraghty, P; Gray, W; Hiatt, WR; Ho, M; Ikeda, K; Ikeno, F; Jaff, MR; Jones, WS; Kawahara, M; Lookstein, RA; Mehran, R; Misra, S; Norgren, L; Olin, JW; Povsic, TJ; Rosenfield, K; Rundback, J; Shamoun, F; Tcheng, J; Tsai, TT; Suzuki, Y; Vranckx, P; Wiechmann, BN; White, CJ; Yokoi, H; Krucoff, MW

Published Date

  • March 2015

Published In

Volume / Issue

  • 65 / 9

Start / End Page

  • 931 - 941

PubMed ID

  • 25744011

Pubmed Central ID

  • 25744011

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

International Standard Serial Number (ISSN)

  • 0735-1097

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2014.12.036

Language

  • eng