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http://hdl.handle.net/1942/27437
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DC Field | Value | Language |
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dc.contributor.author | Garcia-Garcia, Hector M. | - |
dc.contributor.author | McFadden, Eugene P. | - |
dc.contributor.author | Farb, Andrew | - |
dc.contributor.author | Mehran, Roxana | - |
dc.contributor.author | Stone, Gregg W. | - |
dc.contributor.author | Spertus, John | - |
dc.contributor.author | Onuma, Yoshinobu | - |
dc.contributor.author | Morel, Marie-angele | - |
dc.contributor.author | van Es, Gerrit-Anne | - |
dc.contributor.author | Zuckerman, Bram | - |
dc.contributor.author | Fearon, William F. | - |
dc.contributor.author | Taggart, David | - |
dc.contributor.author | Kappetein, Arie-Pieter | - |
dc.contributor.author | Krucoff, Mitchell W. | - |
dc.contributor.author | VRANCKX, Pascal | - |
dc.contributor.author | Windecker, Stephan | - |
dc.contributor.author | Cutlip, Donald | - |
dc.contributor.author | Serruys, Patrick W. | - |
dc.date.accessioned | 2018-11-19T14:43:45Z | - |
dc.date.available | 2018-11-19T14:43:45Z | - |
dc.date.issued | 2018 | - |
dc.identifier.citation | EUROPEAN HEART JOURNAL, 39(23), p. 2192-2207 | - |
dc.identifier.issn | 0195-668X | - |
dc.identifier.uri | http://hdl.handle.net/1942/27437 | - |
dc.description.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. | - |
dc.description.sponsorship | This work was supported by Cardialysis, BV, Rotterdam, The Netherlands. | - |
dc.language.iso | en | - |
dc.publisher | OXFORD UNIV PRESS | - |
dc.subject.other | controlled clinical trials; myocardial infarction; revascularization; scaffold; stents | - |
dc.subject.other | controlled clinical trials; myocardial infarction; revascularization; scaffold; stents | - |
dc.title | Standardized End Point Definitions for Coronary Intervention Trials | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 2207 | - |
dc.identifier.issue | 23 | - |
dc.identifier.spage | 2192 | - |
dc.identifier.volume | 39 | - |
local.format.pages | 16 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | [Garcia-Garcia, Hector M.; Onuma, Yoshinobu; Morel, Marie-angele; van Es, Gerrit-Anne] Cardialysis, Rotterdam, Netherlands. [Garcia-Garcia, Hector M.] MedStar Washington Hosp Ctr, Intervent Cardiol, Washington, DC USA. [McFadden, Eugene P.] Cork Univ Hosp, Intervent Cardiol, Cork, Ireland. [Farb, Andrew; Zuckerman, Bram] US FDA, Washington, DC 20204 USA. [Mehran, Roxana] Icahn Sch Med Mt Sinai, Zena & Michael A Weiner Cardiovasc Inst, New York, NY 10029 USA. [Stone, Gregg W.] Columbia Univ, Med Ctr, Clin Trials Ctr, Cardiovasc Res Fdn, New York, NY USA. [Stone, Gregg W.] Columbia Univ, Med Ctr, Div Cardiol, New York, NY USA. [Spertus, John] Univ Missouri, Mid Amer Heart Inst, Kansas City, MO 64110 USA. [Fearon, William F.] Stanford Univ, Med Ctr, Stanford, CA 94305 USA. [Taggart, David] Univ Oxford, Nuffield Dept Surg, Oxford, England. [Kappetein, Arie-Pieter] Erasmus Med Canter, Thoraxctr, Dept Cardiothorac Surg, Rotterdam, Netherlands. [Krucoff, Mitchell W.] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA. [Vranckx, Pascal] Univ Hasselt, Hartctr Hasselt, Hasselt, Belgium. [Vranckx, Pascal] Univ Hasselt, Fac Med & Life Sci, Hasselt, Belgium. [Windecker, Stephan] Bern Univ Hosp, Bern, Switzerland. [Cutlip, Donald] Harvard Clin Res Inst, Boston, MA USA. [Cutlip, Donald] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA. [Serruys, Patrick W.] Imperial Coll London UK, Ctr Int Cardiovasc Hlth, London, England. | - |
local.publisher.place | OXFORD | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1093/eurheartj/ehy223 | - |
dc.identifier.isi | 000435467200018 | - |
item.validation | ecoom 2019 | - |
item.fulltext | With Fulltext | - |
item.accessRights | Restricted Access | - |
item.fullcitation | Garcia-Garcia, Hector M.; McFadden, Eugene P.; Farb, Andrew; Mehran, Roxana; Stone, Gregg W.; Spertus, John; Onuma, Yoshinobu; Morel, Marie-angele; 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. (2018) Standardized End Point Definitions for Coronary Intervention Trials. In: EUROPEAN HEART JOURNAL, 39(23), p. 2192-2207. | - |
item.contributor | Garcia-Garcia, Hector M. | - |
item.contributor | McFadden, Eugene P. | - |
item.contributor | Farb, Andrew | - |
item.contributor | Mehran, Roxana | - |
item.contributor | Stone, Gregg W. | - |
item.contributor | Spertus, John | - |
item.contributor | Onuma, Yoshinobu | - |
item.contributor | Morel, Marie-angele | - |
item.contributor | van Es, Gerrit-Anne | - |
item.contributor | Zuckerman, Bram | - |
item.contributor | Fearon, William F. | - |
item.contributor | Taggart, David | - |
item.contributor | Kappetein, Arie-Pieter | - |
item.contributor | Krucoff, Mitchell W. | - |
item.contributor | VRANCKX, Pascal | - |
item.contributor | Windecker, Stephan | - |
item.contributor | Cutlip, Donald | - |
item.contributor | Serruys, Patrick W. | - |
crisitem.journal.issn | 0195-668X | - |
crisitem.journal.eissn | 1522-9645 | - |
Appears in Collections: | Research publications |
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