title: Regulatory perspective on embolic protection device approval for saphenous vein graft stenting with a single-arm trial using risk-adjusted prediction model.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Fiorentino
authors.forename: Bram
authors.initials: B
authors.lastname: Zuckerman
authors.forename: Takahiro
authors.initials: T
authors.lastname: Uchida
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000628:therapy*; D018795:Device Approval; D006083:Graft Occlusion, Vascular / Q000628:therapy*; D006801:Humans; D016015:Logistic Models; D015999:Multivariate Analysis; D018570:Risk Assessment / Q000379:methods*; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration