Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document

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...

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Vydané v:	Circulation (New York, N.Y.) Ročník 137; číslo 24; s. 2635
Hlavní autori:	Garcia-Garcia, Hector M, McFadden, Eugène P, Farb, Andrew, Mehran, Roxana, Stone, Gregg W, Spertus, John, Onuma, Yoshinobu, Morel, Marie-Angèle, van Es, Gerrit-Anne, Zuckerman, Bram, Fearon, William F, Taggart, David, Kappetein, Arie-Pieter, Krucoff, Mitchell W, Vranckx, Pascal, Windecker, Stephan, Cutlip, Donald, Serruys, Patrick W
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 12.06.2018
Predmet:	revascularization controlled clinical trials scaffold stents myocardial infarction
ISSN:	1524-4539, 1524-4539
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Abstract	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.
AbstractList	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.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. 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.
Author	Fearon, William F van Es, Gerrit-Anne Windecker, Stephan Farb, Andrew Kappetein, Arie-Pieter Stone, Gregg W Zuckerman, Bram Garcia-Garcia, Hector M McFadden, Eugène P Spertus, John Vranckx, Pascal Taggart, David Cutlip, Donald Krucoff, Mitchell W Morel, Marie-Angèle Mehran, Roxana Serruys, Patrick W Onuma, Yoshinobu
Author_xml	– sequence: 1 givenname: Hector M surname: Garcia-Garcia fullname: Garcia-Garcia, Hector M email: eugene.mcfadden@hse.ie, hect2701@gmail.com, patrick.w.j.c.serruys@gmail.com organization: Interventional Cardiology, MedStar Washington Hospital Center, DC (H.M.G.-G.) – sequence: 2 givenname: Eugène P surname: McFadden fullname: McFadden, Eugène P email: eugene.mcfadden@hse.ie, hect2701@gmail.com, patrick.w.j.c.serruys@gmail.com organization: Interventional Cardiology, Cork University Hospital, Ireland (E.P.M.). eugene.mcfadden@hse.ie hect2701@gmail.com patrick.w.j.c.serruys@gmail.com – sequence: 3 givenname: Andrew surname: Farb fullname: Farb, Andrew organization: US Food and Drug Administration, Washington, DC (A.F., B.Z.) – sequence: 4 givenname: Roxana surname: Mehran fullname: Mehran, Roxana organization: Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.) – sequence: 5 givenname: Gregg W surname: Stone fullname: Stone, Gregg W organization: Clinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.) – sequence: 6 givenname: John surname: Spertus fullname: Spertus, John organization: Mid America Heart Institute, University of Missouri, Kansas City (J.S.) – sequence: 7 givenname: Yoshinobu surname: Onuma fullname: Onuma, Yoshinobu organization: Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.) – sequence: 8 givenname: Marie-Angèle surname: Morel fullname: Morel, Marie-Angèle organization: Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.) – sequence: 9 givenname: Gerrit-Anne surname: van Es fullname: van Es, Gerrit-Anne organization: Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.) – sequence: 10 givenname: Bram surname: Zuckerman fullname: Zuckerman, Bram organization: US Food and Drug Administration, Washington, DC (A.F., B.Z.) – sequence: 11 givenname: William F surname: Fearon fullname: Fearon, William F organization: Stanford University Medical Center, CA (W.F.F.) – sequence: 12 givenname: David surname: Taggart fullname: Taggart, David organization: Nuffield Department of Surgery, University of Oxford, United Kingdom (D.T.) – sequence: 13 givenname: Arie-Pieter surname: Kappetein fullname: Kappetein, Arie-Pieter organization: Department of Cardiothoracic Surgery, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands (A.-P.R.) – sequence: 14 givenname: Mitchell W surname: Krucoff fullname: Krucoff, Mitchell W organization: Duke University Medical Center/Duke Clinical Research Institute, Durham, NC (M.W.K.) – sequence: 15 givenname: Pascal surname: Vranckx fullname: Vranckx, Pascal organization: Hartcentrum Hasselt and Faculty of Medicine and Life Sciences University of Hasselt, Belgium (P.V.) – sequence: 16 givenname: Stephan surname: Windecker fullname: Windecker, Stephan organization: Bern University Hospital, Switzerland (S.W.) – sequence: 17 givenname: Donald surname: Cutlip fullname: Cutlip, Donald organization: Beth Israel Deaconess Medical Center, Boston, MA (D.C.) – sequence: 18 givenname: Patrick W surname: Serruys fullname: Serruys, Patrick W email: eugene.mcfadden@hse.ie, hect2701@gmail.com, patrick.w.j.c.serruys@gmail.com organization: Centre for International Cardiovascular Health, Imperial College London, United Kingdom (P.W.S.) eugene.mcfadden@hse.ie hect2701@gmail.com patrick.w.j.c.serruys@gmail.com
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/29891620$$D View this record in MEDLINE/PubMed
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