000			03246nam a22003377a 4500
008			180619s20182018 xxu||||| |||| 00| 0 eng d
022			_a1936-8798
024			_a10.1016/j.jcin.2018.03.044 [doi]
024			_aS1936-8798(18)30842-2 [pii]
040			_aOvid MEDLINE(R)
099			_a29747912
245			_aDefining Staged Procedures for Percutaneous Coronary Intervention Trials: A Guidance Document. [Review]
251			_aJacc: Cardiovascular Interventions. 11(9):823-832, 2018 May 14.
252			_aJACC Cardiovasc Interv. 11(9):823-832, 2018 May 14.
253			_aJACC. Cardiovascular interventions
260			_c2018
260			_fFY2018
266			_d2018-06-19
501			_aAvailable online through MWHC library: 2008 - present
520			_aCopyright (c) 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
520			_aPatients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee.
546			_aEnglish
650			_aIN PROCESS -- NOT YET INDEXED
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
657			_aReview
700			_aGarcia-Garcia, Hector M
790			_aCollet C, Cutlip DE, de Vries T, Garcia-Garcia HM, Lopes RD, McFadden E, Onuma Y, Ren B, Serruys PW, Spitzer E, Stone GW, Vranckx P
856			_uhttps://dx.doi.org/10.1016/j.jcin.2018.03.044 _zhttps://dx.doi.org/10.1016/j.jcin.2018.03.044
942			_cART _dArticle
999			_c3424 _d3424