Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document
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- Hector M. Garcia-Garcia
- Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.).
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- Eugène P. McFadden
- Interventional Cardiology, Cork University Hospital, Ireland (E.P.M.).
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- Andrew Farb
- US Food and Drug Administration, Washington, DC (A.F., B.Z.).
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- Roxana Mehran
- Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
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- Gregg W. Stone
- Clinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.).
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- John Spertus
- Mid America Heart Institute, University of Missouri, Kansas City (J.S.).
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- Yoshinobu Onuma
- Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.).
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- Marie-angèle Morel
- Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.).
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- Gerrit-Anne van Es
- Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.).
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- Bram Zuckerman
- US Food and Drug Administration, Washington, DC (A.F., B.Z.).
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- William F. Fearon
- Stanford University Medical Center, CA (W.F.F.).
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- David Taggart
- Nuffield Department of Surgery, University of Oxford, United Kingdom (D.T.).
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- Arie-Pieter Kappetein
- Department of Cardiothoracic Surgery, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands (A.-P.R.).
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- Mitchell W. Krucoff
- Duke University Medical Center/Duke Clinical Research Institute, Durham, NC (M.W.K.).
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- Pascal Vranckx
- Hartcentrum Hasselt and Faculty of Medicine and Life Sciences University of Hasselt, Belgium (P.V.).
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- Stephan Windecker
- Bern University Hospital, Switzerland (S.W.).
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- Donald Cutlip
- Harvard Clinical Research Institute, Boston, MA (D.C.).
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- Patrick W. Serruys
- Centre for International Cardiovascular Health, Imperial College London, United Kingdom (P.W.S.)
説明
<jats:p>The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.</jats:p>
収録刊行物
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- Circulation
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Circulation 137 (24), 2635-2650, 2018-06-12
Ovid Technologies (Wolters Kluwer Health)