Regulatory perspective on embolic protection device approval for saphenous vein graft stenting with a single-arm trial using risk-adjusted prediction model

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Veröffentlicht in:Circulation (New York, N.Y.) N.Y.), 2008-02, Vol.117 (6), p.714-716
Hauptverfasser: Fiorentino, Robert P, Zuckerman, Bram, Uchida, Takahiro
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container_title Circulation (New York, N.Y.)
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creator Fiorentino, Robert P
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doi_str_mv 10.1161/CIRCULATIONAHA.107.719617
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source MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete
subjects Angioplasty, Balloon, Coronary
Coronary Disease - therapy
Device Approval
Graft Occlusion, Vascular - therapy
Humans
Logistic Models
Multivariate Analysis
Risk Assessment - methods
Saphenous Vein - transplantation
Stents
United States
United States Food and Drug Administration
title Regulatory perspective on embolic protection device approval for saphenous vein graft stenting with a single-arm trial using risk-adjusted prediction model
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